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Quest Dental USA Corp. Takahiro HaruyamaPresidentGlobizz Corporation1411 W 190th StGardena, California 90248October 19, 2017Re: K172281Trade/Device Name: PuRE PMMA DiscRegulation Number: 21 CFR 872.3770Regulation Name: Temporary Crown And Bridge ResinRegulatory Class: Class IIProduct Code: EBGDated: August 3, 2017Received: August 4, 2017Dear Takahiro Haruyama:We have reviewed your Section 510(k) premarket notification of intent to market the device referencedabove and have determined the device is substantially equivalent (for the indications for use stated in theenclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, theenactment date of the Medical Device Amendments, or to devices that have been reclassified in accordancewith the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of apremarket approval application (PMA). You may, therefore, market the device, subject to the generalcontrols provisions of the Act. The general controls provisions of the Act include requirements for annualregistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbrandingand adulteration. Please note: CDRH does not evaluate information related to contract liability warranties.We remind you, however, that device labeling must be truthful and not misleading.If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may besubject to additional controls. Existing major regulations affecting your device can be found in the Code ofFederal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcementsconcerning your device in the Federal Register.Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDAhas made a determination that your device complies with other requirements of the Act or any Federalstatutes and regulations administered by other Federal agencies. You must comply with all the Act'srequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); goodmanufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR1000-1050.U.S. Food & Drug Administration10903 New Hampshire AvenueSilver Spring, MD 20993www.fda.govDoc ID# 04017.01.96

Page 2 - Takahiro HaruyamaK172281If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact theDivision of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 7967100 or at its Internet address Industry/default.htm.Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part803), please go to oblem/default.htm for the CDRH'sOffice of Surveillance and Biometrics/Division of Postmarket Surveillance.You may obtain other general information on your responsibilities under the Act from the Division ofIndustry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at itsInternet address Industry/default.htm.Sincerely,Mary S. Runner -Sfor Tina Kiang, Ph.D.Acting DirectorDivision of Anesthesiology,General Hospital, Respiratory,Infection Control, and Dental DevicesOffice of Device EvaluationCenter for Devices and Radiological HealthEnclosure

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Quest Dental – PuRE PMMA DiscTraditional 510(k) SubmissionSection 5 – 510(k) SummaryPage 5-1SECTION 5: 510(k) Summary5.1: Submitter InformationK172281510(k) Owner/ApplicantQuest Dental USA Corp17865 Sky Park Circle, Ste. L1Irvine, CA 92614Official CorrespondentTakahiro HaruyamaGlobizz Corporation1411 W. 190th St., Ste. 200Gardena, CA 90248Tel: (310) 538-3860Email: register@globizz.netDate PreparedJuly 21, 20175.2: Device IdentificationTrade NamePuRE PMMA DiscCommon NamePMMA DiscClassification NameTemporary Crown and Bridge ResinClassification Regulation872.3770Review PanelDentalProduct CodeEBGDevice ClassClass II5.3: Predicate and Reference DevicesPredicate Device510(k) No.: K093708Device Name: TELIO CADSubmitter/Applicant: Ivoclar Vivadent, IncorporatedReference Devices forComposition andBiocompatibility1. 510(k) No.: K151764Device Name: Yamahachi PMMA DisksSubmitter/Applicant: Yamahachi Dental Products USA, Inc.2. 510(k) No.: K132937Device Name: Harvest Dental Polymer Blocks (ZCAD)Submitter/Applicant: Harvest Dental Products, LLC3. 510(k) No.: K973513Device Name: ESPE Sinfony Opaquer PowderSubmitter/Applicant: ESPE GMBH & CO. KG.Version 1

Quest Dental – PuRE PMMA DiscTraditional 510(k) SubmissionSection 5 – 510(k) SummaryPage 5-25.4: Device DescriptionPuRE PMMA Discs are polymethyl methacrylate blanks used to mill dental long-term temporary crowns andbridges in various CAD/CAM systems until permanent restorations can be delivered. Restorations aredesigned and manufactured by dental professionals and technicians using open CAD/CAM technology. Thediscs are provided non-sterile, without any accessories, and are indicated for single-use only.The device is composed of polymethyl methacrylate and pigments. PuRE PMMA discs are available in 23shades and varying thicknesses (14-30 C4D4BL4BL55.5: Indications for Use StatementPuRE PMMA Discs are polymethyl methacrylate blanks used to mill dental long-term temporary crowns andbridges in various CAD/CAM systems until permanent restorations can be delivered. Restorations aredesigned and manufactured by dental professionals and technicians using open CAD/CAM technology.5.6: Comparison of Device CharacteristicsTable 5-A. Comparison of device characteristics to predicate and reference devices.510(k) No.ApplicantDevice NameSubject DeviceNot yet assignedPredicate DeviceK093708Quest Dental U.S.A.Corp.Ivoclar VivadentPuRE PMMA DiscTELIO CADRegulation No.21 CFR 872.377021 CFR 872.3770Product CodeEBGEBGIndications forusePuRE PMMA Discs arepolymethylmethacrylate blanksused to mill dentallong-term temporarycrowns and bridgesin various CAD/CAMsystems untilpermanentFor the fabrication oftemporary crownsand bridges using theCAD/CAM technologyuntil the permanentrestoration can bedelivered.Version 1Reference Devices1. K1517642. K1329373. K9735131. Yamahachi DentalProducts USA, Inc.2. Harvest DentalProducts, LLC3. ESPE GMBH & CO. KG.1. Yamahachi PMMA Disks2. Harvest Dental PolymerBlocks (ZCAD)3. ESPE Sinfony OpaquerPowder1. 21 CFR 872.37702. 21 CFR 872.37703. 21 CFR 872.36901. EBG2. EBG3. EBFComparison----The subjectdevice isregulated thesame asK093708,K151764, andK132937.Same.

Quest Dental – PuRE PMMA DiscTraditional 510(k) SubmissionSection 5 – 510(k) SummaryPage 5-3restorations can bedelivered.Restorations aredesigned andmanufactured bydental professionalsand technicians usingopen CAD/CAMtechnology.TechnologicalCharacteristicsHow Device sPowder and liquidmethacrylate-basedresins mixed togetherand heat curedPMMA pigmentsPowder and liquidmethacrylate-basedresins mixed togetherand heat curedPMMA pigmentsBiocompatibleMet the acceptancecriteria of ISO10477:2004 and JIST 6518:2011.BiocompatibleMet the acceptancecriteria of ISO10477:2004Same.PMMA, pigmentsBiocompatibleThe subjectdevice iscomposed ofthe same orsimilar materialsused in thepredicate andreferencedevices.Same.Same.5.7: Statement of Substantial EquivalenceThe subject and predicate devices are similar in intended use, technological characteristics, and compositionof construction materials. Standardized performance and biocompatibility assessments, as well asdifferences between the devices, did not raise any new concerns regarding safety and effectiveness. Theconclusions drawn from the non-clinical performance tests demonstrate that the PuRE PMMA Disc issubstantially equivalent to the referenced predicate device.Version 1

Quest Dental - PuRE PMMA Disc Section 5 - 510(k) Summary Traditional 510(k) Submission Page 5-1 Version 1 SECTION 5: 510(k) Summary 5.1: Submitter Information 510(k) Owner/Applicant Quest Dental USA Corp 17865 Sky Park Circle, Ste. L1 Irvine, CA 92614 Official Correspondent Takahiro Haruyama Globizz Corporation 1411 W. 190th St., Ste. 200