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EC CERTIFICATE

Number: 2162627CE02

Full Quality Assurance SystemDirective 93/42/EEC on Medical devices, Annex II excluding (4)(Devices in Class lla, lib or III)

Manufacturer:

Institut Straumann AGPeter-Merian-Weg 124002 BaselSwitzerland

For the product category(ies)

Regenerative materials containing Animal Tissues: ''//////./[l//lll,Material for Periodontal Regeneration and intra-oral woundhealing

DEKRA grants the right to use the EC Notified Body Identification Number illustrated below to accompany;the CE Marking of Conformity on the products concerned conforming to the required Technical injiDocumentation and meeting the provisions of the EC-Directive which apply to them: , / ,;;,'

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Documents, that form the basis of this certificate:

Certification Notice 2162627CN, initially dated 10 July 2013

DEKRA hereby declares that the above mentioned manufacturer fulfils the relevant provisions of 'Besluit MedischeHulpmiddelen', the Dutch transposition of the Council Directive 93/42/EEC of June 14, 1993 concerning Medicaldevices, including all subsequent amendments. The manufacturer has implemented a quality assurance system fordesign, manufacture and final inspection for the above mentioned product category in accordance to the provisions ofAnnex II of Council Directive 93/42/EEC of June 14, 1993 and is subject to periodical surveillance. For placing on themarket of Class III devices an additional EC design examination certificate according to Annex II (4) is mandatory.The necessary information related to the quality management system of the manufacturer, including facilities and thereference to the relevant documentation, of the products concerned and the assessments performed, are stated in theCertification Notice which forms an integrative part of this certificate.

This certificate is valid until:Issued for the first time:Reissued:

DEKRA Certification B.V.

1 December 202317 March 20166 December 2018

B.T.M. HoltusManaging Director

^^J.A. van VugtCertification Manager

© Integral publication of this certificate and adjoining reports is allowed

DEKRA Certification B.V. is Notified Body with ID no 0344

DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The NetherlandsT +31 88 96 83000 F +31 88 96 83100 (flmw.dekra-certification.com Company registration 09085396

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EC CERTIFICATE

Number: 2162627CE04

Full Quality Assurance SystemDirective 93/42/EEC on Medical devices, Annex II excluding (4)(Devices in Class lla, lib or III)

Manufacturer:

Institut Straumann AGPeter-Merian-Weg 124002 BaselSwitzerland

For the product category(ies)

Synthetic regenerative materials:- Bone substitutes, Resorbable, Osteoconductive Bone Filler- Dental material for removal of the smear layer

DEKRA grants the right to use the EC Notified Body Identification Numberillustrated below to accompany;",'the CE Marking of Conformity on the products concerned conforming to the required TechnicalDocumentation and meeting the provisions of the EC-Directive which applyto.t^^m:

0344Documents, that form the basis of this certificate:

Certification Notice 2162627CN, initially dated 10 July 2013

DEKRA hereby declares that the above mentioned manufacturer fulfils the relevant provisions of 'Besluit MedischeHulpmiddelen', the Dutch transposition of the Council Directive 93/42/EEC of June 14, 1993 concerning Medicaldevices, including all subsequent amendments. The manufacturer has implemented a quality assurance system fordesign, manufacture and final inspection for the above mentioned product category in accordance to the provisions ofAnnex II of Council Directive 93/42/EEC of June 14, 1993 and is subject to periodical surveillance. For placing on themarket of Class III devices an additional EC design examination certificate according to Annex II (4) is mandatory.The necessary information related to the quality management system of the manufacturer, including facilities and thereference to the relevant documentation, of the products concerned and the assessments performed, are stated in theCertification Notice which forms an integrative part of this certificate.

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This certificate is valid until:Issued for the first time:Reissued:

DEKRA Certification B.V.

1 December 202317 March 20166 December 2018

B.T.M. HoltusManaging Director

^^J.A. van VugtCertification Manager

© Integral publication of this certificate and adjoining reports is allowed

DEKRA Certification B.V. is Notified Body with ID no 0344

DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The NetherlandsT +31 88 96 83000 F +31 88 96 83100 www.dekra-certification.com Company registration 09085396

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EC CERTIFICATE

Number: 2162627CE05

Full Quality Assurance SystemDirective 93/42/EEC on Medical devices, Annex II excluding (4)(Devices in Class lla, lib or III) JUIiS.

Manufacturer: ^SIBiInstitut Straumann AG ^iiif//!/li,Peter-Merian-Weg 12 ^"I%liJ%%^

Switzerland '•';'/:///111.

For the product category(ies)

Non active implantable bone substitute material, bovine origin

DEKRA grants the right to use the EC Notified Body Identification Number illustrated below to accompany/,the CE Marking of Conformity on the products concerned conforming to the required Technical f ,';Documentation and meeting the provisions of the EC-Directive which apply to them:

0344Documents, that form the basis of this certificate:

Certification Notice 2162627CN, initially dated 10 July 2013Addendum, initially dated 15 November 2016

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DEKRA hereby declares that the above mentioned manufacturer fulfils the relevant provisions of 'Besluit MedischeHulpmiddelen', the Dutch transposition of the Council Directive 93/42/EEC of June 14, 1993 concerning Medicaldevices, including all subsequent amendments. The manufacturer has implemented a quality assurance system fordesign, manufacture and final inspection for design, manufacture and final inspection for the above mentioned productcategory in accordance to the provisions of Annex II of Council Directive 93/42/EEC of June 14, 1993 and is subject toperiodical surveillance. Additionally, DEKRA hereby declares that the manufacturer fulfils the relevant provisions asspecified in Annex I of Commission Regulation 722/2012 of 8 August, 2012 concerning medical devices manufacturedutilising tissue of animal origin. For placing on the market of Class III devices an additional EC design examinationcertificate according to Annex II (4) is mandatory.The necessary information related to the quality management system of the manufacturer, including facilities and thereference to the relevant documentation, of the products concerned and the assessments performed, are stated in theCertification Notice which forms an integrative part of this certificate.

This certificate is valid until: 20 January 2020Issued for the first time: 15 November 2016Reissued: 25 May 2018

DEKRA Certification B.V.

drs. G.J. ZoetbroodManaging Director

ing. A.A.M. LaanCertification Manager

© Integral publication of this certificate and adjoining reports is allowed

DEKRA Certification B.V. is Notified Body with ID no 0344

DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The NetherlandsT +31 88 96 83000 F +31 88 96 83100 www.dekra-certification.com Company registration 09085396

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ADDENDUM

Belonging to certificate: 2162627CE05

CE MARKING OF CONFORMITYMEDICAL DEVICES

Non active implantable bone substitute material, bovine origin

Issued to:

Institut Straumann AGPeter-Merian-Weg 124002 BaselSwitzerland

This certificate covers the following productfs^

- Straumann® XenoOss- Straumann ©Cerabone

Initial date: 15 November 2016Revision date: 2 December 2016

DEKRA Certification B.V.

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drs. G.J. ZoetbroodManaging Director

ing. A.A.M. LaanCertification Manager

© Integral publication of this certificate and adjoining reports is allowed

DEKRA Certification B.V. is Notified Body with ID no 0344

DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The NetherlandsT +31 88 96 83000 F +31 88 96 83100 www.dekra-certification.com Company registration 09085396

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EC CERTIFICATE

Number: 2162627CE06

Full Quality Assurance SystemDirective 93/42/EEC on Medical devices, Annex II excluding (4)(Devices in Class lla, lib or III)

Manufacturer:

Institut Straumann AGPeter-Merian-Weg 124002 BaselSwitzerland

For the product category(ies)

Absorbable collagen membrane, porcine origin

DEKRA grants the right to use the EC Notified Body Identification Number illustrated below to accompany,the CE Marking of Conformity on the products concerned conforming to the required TechnicalDocumentation and meeting the provisions of the EC-Directive which apply to them:

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Documents, that form the basis of this certificate:

Certification Notice 2162627CN, initially dated 10 July 2013Addendum, initially dated 15 November 2016

DEKRA hereby declares that the above mentioned manufacturer fulfils the relevant provisions of 'Besluit MedischeHulpmiddelen', the Dutch transposition of the Council Directive 93/42/EEC of June 14, 1993 concerning Medicaldevices, including all subsequent amendments. The manufacturer has implemented a quality assurance system fordesign, manufacture and final inspection for design, manufacture and final inspection for the above mentioned productcategory in accordance to the provisions of Annex II of Council Directive 93/42/EEC of June 14, 1993 and is subject toperiodical surveillance. Additionally, DEKRA hereby declares that the manufacturer fulfils the relevant provisions asspecified in Annex I of Commission Regulation 722/2012 of 8 August, 2012 concerning medical devices manufacturedutilising tissue of animal origin. For placing on the market of Class III devices an additional EC design examinationcertificate according to Annex II (4) is mandatory.The necessary information related to the quality management system of the manufacturer, including facilities and thereference to the relevant documentation, of the products concerned and the assessments performed, are stated in theCertification Notice which forms an integrative part of this certificate.

This certificate is valid until:Issued for the first time:Revised:

DEKRA Certification B.V.

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18 June 201915 November 201625 January 2017

drs. G.J. ZoetbroodManaging Director

ing. A.A.M. LaanCertification Manager

© Integral publication of this certificate and adjoining reports is allowed

DEKRA Certification B.V. is Notified Body with ID no 0344

DEKRA Certification B.V. Meander 1051 , 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The NetherlandsT +31 88 96 83000 F +31 88 96 83100 www.dekra-certification.com Company registration 09085396

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ADDENDUM

Belonging to certificate: 2162627CE06

CE MARKING OF CONFORMITYMEDICAL DEVICES

Absorbable collagen membrane, porcine origin

Issued to:

Institut Straumann AGPeter-Merian-Weg 124002 BaselSwitzerland

This certificate covers the following

- Straumann® GBR Membrane- Straumann® Jason Membrane

Initial date: 15 November 2016Revision date: 2 December 2016

DEKRA Certification B.V.

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wiii^/w//rflMh.•/:<-<;^%/r;//4wl//i"/''/7/.'::7^/^f

drs. G.J. ZoetbroodManaging Director

ing. A.A.M. LaanCertification Manager

© Integral publication of this certificate and adjoining reports is allowed

DEKRA Certification B.V. is Notified Body with ID no 0344

DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem, The NetherlandsT+31 88 96 83000 F+31 88 96 83100 www.dekra-certification.com Company registration 09085396