wryQ U A L I T Y S Y S T E M

C E R T I F I C A T E

concerning medical devices, Annex II, Section 3.

Manufacturer: Planmeca OyAsentajankatu 6FIN-00880 HelsinkiFinland

coverage of certificate: Design, manufacture and final inspection

Product category: Dental diagnosti c X-ray equipment andaccessories. Dental units and patient chairs

23rd November 2010

Council Directive 93l42lEEC of 14 June 1993

Valid until:

The manufacturer's quality system for the design, manufacture and final inspectionof the aforesaid product category has been evaluated and meets the provisions ofCouncil Directive 93l42lEEC as set out in Annex II Section 3. This approval is validuntil the expiry date provided that the manufacturer fulfils the obligations imposedby Annex II in Directive 93l42|EEC. This Certificate is based on decision no.v TT -C -2287 -0 r - | 007 -3 05 -07-P0.

Seppo Lavonen

Certificate no.

v TT -C -2287 -0 | - 1 007 -3 0 5 -07

Translated from Finnish orisinal.

Kaarle Kylmiilii

Notif ied Bodv no. 0537:Technical Research Centre of FinlandP.O. Box 1300 (Tekniikankatu 1)

FIN-33IOI TAMPERETel .+358 3 316 3 l l l

Tampere, 23rd November 2007

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DE.CISIONon a quality system and product range covered, based on CouncilDirective 93l42lEEC of 14 June 1993 concerning medical devices,

Annex II. Section 3.

Decision no.: vTT -C-2287-0 1 -1 007-305-07-P0Extension of the validity period.

Manufacturer: Planmeca OyAsentaj ank a'oi 6, FIN-00 8 8 00 HelsinkiFinland

Date of application: 22.10.2007

Activity and productcategory:

Design, manufacture and final inspection of diagnostic dental X-rayequipment and accessories and dentql units and patient chairs.

Decision: A certificate will be issued for the manufacturer. The certificatecovers the following products:

X-ray devices and accessories:- Planmeca ProOne, Panoramic X-ray- Planmeca ProMax 3D, Panoramic X-ray- Planmeca Proline XC, Panoramic X-ray- Planmeca Proline EC, Panoramic X-ray,- Planmeca Dimax 2,Digital Panoramic X-ray System- Planmeca Dimax 3, Digital Panoramic X-ray System- Planmeca Dimaxis Classic- Planmeca Dimaxis Pro- Planmeca Intra, Intraoral X-ray- Planmeca Dixi, Digital Intra X-ray System- Planmeca Promax, Panoramic X-rayDental units and accessories:- Planmeca Compact i, Dental Unit- Planmeca Compact a, Dental Unit- Planmeca Compact e, Dental Unit- Planmeca Universal. Dental Unit

class IIbclass IIbclass IIbclass IIbclass IIbclass IIbclass IIbclass IIbclass IIbclass IIaclass IIb

class IIaclass IIaclass IIaclass IIa

Justification: The manufacturer's certificate no. TUO 1007-206 expires23rdNovember 2007. The manufacturer's quality system has beenreassessed and VTT has found that the quality system and theproducts meet the requirements of Annex II of Medical DeviceDirective 93l42lEEC in design, manufacture and final inspection.The decision is based on the audit report no. NB-I007-A16 andChange Assessment Report No.NB- 1 007-MR08.

VTT is Notified Body no 0537 under Council Directive 93l42lEEC.VTT TEGHNICAL RESEARCH GENTRE OF FINLANDMedical Device TechnologyTekniikankatu 1, Tampere Tel. +358 20 722 111 www.vtt.fiP.O. BOX 1300, Fl-33101 TAMPERE Fax+358 207223365 Business tD0244679-4FINLAND

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The company has signed the undertaking to follow the obligationsof Annex II of the Directive.

vTT -C-2287-0 1 -1007-305-07

Valid until: This decision is valid until23'd November 2010.

Tampere 23'd November 2007

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