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Registration InformationNotified Body, #:Address:CE Certificate #BSI (0086)Kitemark Court, Davy Avenue,Knowlhill, Milton Keynes,MK5 8PP, UKCE 649654Conformity AssessmentApplicable CouncilDirective .Classification .Route to Compliance.Orthodontic Design and Production2165 Earlywood DriveFranklin, IN 46131, United StatesStandards Applied .T: 1 (317) 346-6655F: 1 (317) 346-666393/42/EEC(as amended by 2007/47/EC)Class IIa (Rule 5, Annex IX)Annex VISO 13485:2016Certificate #: FM 659830European Authorized Representativemdi Europa GmbHLangenhagen Str. 71 30855 LangenhagenGermanyE-mail: orders@ghortho.comD ECLARATION OF CONFORMITYClass IIa ProductsUMDNS Code on-latex Intraoral ElasticsNon-latex Intraoral ElasticsHooksAuxiliary J HooksBall ClaspsCrimpable StopsExtrusion HooksEyeletsLingual ButtonsLingual CleatsLugsShepherds HooksSurgical & Arch HooksCeramic Lingual ButtonCeramic HooksT-HooksOrthodontic ExpandersPalatal BarsQuad HelixLip BumpersLigature WiresBulk Ligature WireKobayashi TiesPreformed LigaturesPart number Prefix(Part Number begins with 0-*SBLW*KH01*LT*SKH*SLT*M021B-*(list continues)Name/TitleSignatureDateTMP.90.004.0 ODP – Class IIa EU Declaration of Conformity (Sep-2018)Page 1 of 5
ODP EU Declaration of Conformity, Class IIa, continuedUMDNS Code Product Family/DescriptionPart number Prefix(Part Number begins with )16-05516-190Expansion ScrewsExpansion ScrewsPalatal Expansion ScrewsElastic Bands, OrthodonticArchwire Protective SleeveChain Elastic, ContinuousChain Elastic, LongChain Elastic, ShortPowerLinx Chain ElasticEnchanted Intraoral ElasticsExtreme ElasticsPL Elastics16-19816-199OC ElasticsExtraoral ElasticsVersa-Tie Patient TiesBambino Patient TiesMini Patient TiesSupreme Patient TiesSelect Patient TiesDesigner Patient TiesCaned Patient TiesBulk Patient TiesThreads, HollowThreads, SolidRotation WedgesOrthodontic BandsTitan Molar BandsSaturn Molar BandsSaturn Bicuspid BandsPL Molar BandsPL Bicuspid BandsOrthodontic TubesViper Buccal TubesViper CV Buccal TubesMagnum Buccal TubesMiniPrevail Buccal S1B*NS7B*(list continues)Name/TitleSignatureDateTMP.90.004.0 ODP – Class IIa EU Declaration of Conformity (Sep-2018)Page 2 of 5
ODP EU Declaration of Conformity, Class IIa, continuedUMDNSCode16-19916-204Product Family/DescriptionPart number Prefix(Part number begins with )Orthodontic Tubes (Continued .)Coralex Buccal TubesNS3-036*Straight-Line Buccal TubesBBT*WBT*Lingual SheathsM040-*WLS05*WLS15*V-TubesV-T*Tubes - MiscM001*M060*M061*M090*Orthodontic WiresBrass WireSTBR*AW820*Colboloy Blue WireCBBF*CBF*CBSTR*CBTF*Nickel Titanium Wire, includes coated wiresG4 & Super Elastic SESL*SETF*SEXL*W1622*W71*W83*W90*W93*OSN*M5 & Thermal TSM*W80*W81*W82*W91*G4 & Super Elastic ReverseG4RC*PTNRC*RC1*RCD*CurveW68*W78*M5 & Thermal Reverse Curve CURC*M1RC*M5RC*TRC*NTC Basic103884*104832*Spooled & 7” LengthsSENT*SESP*TNT*Archwire KitsPP*Stainless Steel Wire, including coated wiresAustralian WireAJW*AW2*AW6*AW7*AWTF*Stainless Steel TF*W50*W54*W55*W92*XRALL* Archwires, Spooled & 14”)MS8*S6SF*SSP*SST3*SST7*Retraction Arches (Looped)KHTF*TLPTF*TLTF*Posted ArchwiresPSBF*PSEF*PSTF*PXB*W50UP*1037*P14” LengthsSTSS*Soft F*W72*XRSF*MS7*SST6*W50LP*( list continues)Name/TitleSignatureDateTMP.90.004.0 ODP – Class IIa EU Declaration of Conformity (Sep-2018)Page 3 of 5
ODP EU Declaration of Conformity, Class IIa, ptionPart number Prefix(Part number begins with )TitanMolyTM Titanium Molybdenum Wire / Beta BT3TitanMoly MTF*TMXL*W60*W62*Retraction Arches (Loops)B3TL*BTTL*TMTL*14” LengthsBTSTR*STB3*STTM*Orthodontic BracketsCeramic BracketsClarion Ceramic Brackets50-*50K-*51-*52-*52K-*Diamante Ceramic Brackets55-*55K-*56-*57-*57K-*58-*Mirage Ceramic Brackets60-*60K-*61-*62-*62K-*63-*Vapor Ceramic Brackets75-*75K-*76-*Venus Ceramic BracketsKTVCR*VCR*Zenith Ceramic BracketsEDCR*KTECR*KTEDCR*RCR*Composite BracketsLucent Composite Brackets4040K-*41-**Prism Composite BracketsZenith Composite BracketsStainless Steel BracketsAgility BracketsApollo BracketsComfort Zone BracketsFocus BracketsMagnum BracketsMiniPrevailBicuspid/Molar BracketsStraight-line K-*23K-*31K*34K*37K*120-*KTNVR*RXA*( list continues)Name/TitleSignatureDateTMP.90.004.0 ODP – Class IIa EU Declaration of Conformity (Sep-2018)Page 4 of 5
ODP EU Declaration of Conformity, Class IIa, continuedUMDNSCodeProduct Family/Description90-503Orthodontic SpringsClosed Coil Nickel Titanium SpringsPart number Prefix(Part number begins with )Closed Coil Stainless Steel SpringsMolar Distalizing Nickel Titanium SpringsOpen Coil Nickel Titanium SpringsOpen Coil Stainless Steel *SSOC*We, Orthodontic Design and Production (ODP) of Franklin, Indiana, USA, declare with soleresponsibility that the products listed above meet the essential requirements of the CouncilDirective 93/42/EEC, as amended by 2007/47/EC, pertaining to Medical Devices.Signed this 23rd day of September, 2018 byEveline Carr, Regulatory ManagerThis document expires 5 years from the above date.We hereby appoint mdi Europa GmbH, Langenhagener Str. 79, 30855 Langenhagen in Germany to act asEuropean Authorized Representative, as explicitly stated in Article 1, §2(j) of Directive 93/42/EEC.The necessary pre-requisites for placing the CE 0086 mark on the above mentioned products, andmarketing this in all Member States of the European UnionName/TitleSignatureDateTMP.90.004.0 ODP – Class IIa EU Declaration of Conformity (Sep-2018)Page 5 of 5
UMDNS Code Product Family/Description Part number Prefix (Part Number begins with ) 11-394 Non-latex Intraoral Elastics Non-latex Intraoral Elastics LFH* LFM* 12-028 Hooks Auxiliary J Hooks M002-* Ball Clasps SSBC* Crimpable Stops CSTOP* M022-* M025-* Extrusion Hooks EXHK* Eyelets CME* M005B* M006B*
