TempoCem Clear

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff entwined with a serpent. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 30, 2016 Dmg Usa, Inc. % Pam Papineau Consultant, President Delphi Medical Device Consulting, Inc. 5 Whitcomb Ave Ayer, Massachusetts 01432 Re: K160443 Trade/Device Name: Tempocem Clear Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: August 30, 2016 Received: September 2, 2016 Dear Pam Papineau: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and 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 be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Susan Runno DDS, MA Tina Kiang, PhD Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) Device Name TempoCem Clear Indications for Use (Describe) TempoCem Clear is indicated for: - · Temporary or semipermanent luting of temporary and permanent crowns, bridges, inlays and onlays. - · Temporary luting of temporary veneers Type of Use (Select one or hoth, as annlicable) - · Temporary or semipermanent luting of implant-borne dental prosthesis. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <div> <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### Section 5 - 510(k) Summary 1. Submitter Information DMG USA, Inc. 23 Frank Mossberg Drive Attleboro, MA 02703, USA Phone: (508) 226-5660 Fax: (508) 226-7528 Contact Person: Pamela Papineau, RAC (US, EU, CAN) Phone: (978) 772-3552 Fax: (978) 796-5460 E: delphimdc@comcast.net Date prepared: 27 September 2016 2. Device Name Name of device: TempoCem Clear Common name: Temporary dental cement Requlation number: 21 CFR 872.3275(b) Classification name: Dental Cement Regulatory device class: II Product code: EMA 3. Predicate Device Primary predicate: Telio CS Link Systemp.link (K042846). Reference predicate: Telio CS Cem Implant (K120432). ### 4. Device Description TempoCem Clear is a transparent, dual-curing, resin-based dental cement for the temporary or semipermanent cementing of provisional resin-based composite restorations (crowns, bridges, inlays, onlays, veneers) to a tooth and for temporary or semipermanent luting to an implant abutment. The cement consists of two pastes (base and catalyst) packaged in a double-barreled plastic syringe. The pastes are automatically mixed when dispensed through the single-use mixing tips supplied with the device. #### 5. Indications for Use - · Temporary or semipermanent luting of temporary and permanent crowns, bridges, inlavs and onlays. - · Temporary luting of temporary veneers. - · Temporary or semipermanent luting of implant-borne dental prosthesis. {4}------------------------------------------------ ### 6. Comparison to the Predicate Device A comparison of TempoCem Clear with the primary predicate device indicates the following similarities and differences. | Definition or<br>Property [unit] | TempoCem Clear<br>(proposed device)<br>(K160443) | Telio CS Link<br>(predicate device)<br>(K042846) | |--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common name | Temporary dental cement | Temporary dental cement | | Classification name | Cement, Dental<br>21 CFR 872.3275 (b) | Cement, Dental<br>21 CFR 872.3275 (b) | | Product code | EMA | EMA | | Indications for Use | Temporary or semipermanent<br>luting of temporary and<br>permanent crowns, bridges,<br>inlays and onlays.<br>Temporary luting of temporary<br>veneers.<br>Temporary or semipermanent<br>luting of implant-borne dental<br>prosthesis. | Temporary cementation of<br>provisional restorations.<br>The product has been designed<br>to remain in the mouth for a<br>maximum of 6 weeks. | | Composition | Glass filling material in a matrix<br>of multifunctional<br>methacrylates. Catalyst,<br>stabilizer, additives. Free from<br>methyl methacrylate and<br>peroxides. Percentage of filler:<br>$40 wt % = 22 vol.% (0.02 -2.5 μm)$ . | Telio CS Link is composed of<br>bismethacrylates (56 wt.%)<br>and fillers (43 wt.%). Initiators,<br>stabilizers and pigments are<br>additional ingredients. | | Curing mechanism | Dual-curing | Dual-curing | | Maximum solubility<br>measured as water<br>solubility, dual-cure<br>[µg/mm³] | $19.0 ± 1.3$ | $9.1 ± 0.6$ | | Water sorption, dual-<br>cure [µg/mm³] | $65.5 ± 2.0$ | $77.3 ± 1.4$ | | Dimensional change<br>after 7 days, dual-cure<br>[%] | $1.0 ± 0.1$ | $1.7 ± 0.1$ | | Gel time, self-cure [s] | 65 | 165 | | Setting time, self-cure,<br>measured as final<br>setting time, excluding<br>30 s mixing time [s] | 318 | 216 | | Bonding strength for<br>intended use, dual-cure | Good to satisfactory | Good to satisfactory | | Film thickness, dual-<br>cure [µm] | $6 ± 1$ | $39 ± 3$ | | Amount of heat<br>generated during | $43.1 ± 1.3$ | $43.0 ± 0.5$ | | Definition or<br>Property [unit] | TempoCem Clear<br>(proposed device)<br>(K160443) | Telio CS Link<br>(predicate device)<br>(K042846) | | setting (dual-cure),<br>measured as peak<br>polymerization<br>temperature [°C] | | | | Compressive strength,<br>dual-cure [MPa] | 78 ± 8 | 43 ± 6 | | Flexural strength, dual-<br>cure [MPa] | 5.4 ± 0.3 | 6.4 ± 0.2 | | Shear bond strength,<br>dual-cure [MPa] | 8.7 ± 1.9 | 7.8 ± 2.0 | | Fluoride release,<br>measured as<br>cumulative value over<br>28 days, dual-cure<br>[ppm] | 8.0 ± 2.2 | No data<br>(does not contain NaF) | {5}------------------------------------------------ TempoCem Clear is similar to the predicate device Telio CS Link in that they are both automixing, transparent, dual-curing temporary resin dental cements to be used for cementing restorations such as crowns, bridges, inlays and onlays. The devices have substantially equivalent physical and mechanical properties. TempoCem Clear is different from the predicate device in that it contains sodium fluoride. The subject and predicate devices have slightly different Indications for Use language. The Indications for Use for Telio CS Link do not mention, but do not exclude, the use for specific restorations (temporary and permanent crowns, bridges, inlays, onlays, and veneers). The Intended Use for Telio CS Link as presented in the K042846 Summary was: "For the temporary cementation of temporary inlays, onlays, partial crowns, crowns or bridges." The differences in the Indications for Use affect neither the Intended Use nor substantial equivalence. The reference predicate device, Telio CS Cem Implant, has the same FDA Product Code (EMA= Dental cement) as TempoCem Clear. Telio CS Cem Implant is a selfcuring resin cement with lightcuring option for the esthetic, temporary, reversible / semi-permanent cementation of restorations on implant abutments. The Indications for Use for Telio CS Cem Implant ("Reversible/semi-permanent cementation of longterm temporary and permanent restorations on implant abutments") are similar to the specific Indication for Use for TempoCem Clear ("Temporary or semipermanent luting of implant-borne dental prosthesis."). The composition of Telio CS Cem Implant (bismethacrylates (approx. 52 %wt.) and fillers (approx. 46 %wt.). Initiators, stabilizers, auxiliaries and piqments are additional components.) is substantially equivalent to TempoCem Clear. Thus TempoCem Clear is similar to the reference predicate Telio CS Cem Implant in composition, curing and indications. ## 7. Non-Clinical Performance Data Physical and mechanical properties of TempoCem Clear were investigated and compared to the predicate device in accordance with FDA's 1998 Guidance for Industry and FDA Staff: Dental Cements - Premarket Notification (chemistry of the {6}------------------------------------------------ setting reaction, working and setting times, solubility, dimensional change, bonding strength, film thickness, heat generated during setting and biocompatibility), Comparative data relevant for temporary, dual-curing cements demonstrate substantial equivalence of TempoCem Clear to the predicate device, Telio CS Link. The biocompatibility testing was performed according to the FDA 1998 Guidance and the following consensus standard: - ISO Standard 7405 Second edition (2008): Dentistry Evaluation of biocompatibility of medical devices used in dentistry Equivalence in biocompatibility to the predicate device was demonstrated in cytotoxicity studies. In addition, TempoCem Clear can be compared to other currently marketed dental products also manufactured by DMG: Luxatemp Ultra (K101710), Luxatemp / Luxatemp-Solar (K013674) and Luxatemp Automix (K924830). These dual-cure or auto-cure devices are not temporary cements, but have many similarities in curing mechanism and composition with TempoCem Clear. For example, the same auto-cure system and many of the same resin and pigment components are used in TempoCem Clear. The Luxatemp products have been marketed world-wide for over 25 years, and there is considerable clinical experience with these products and their components. This experience provides further evidence for the biocompatibility of the materials in TempoCem Clear. ### 8. Clinical Performance Data Not applicable. Clinical performance testing has not been performed for the proposed device. ### 9. Conclusions . Based on the device Indications for Use, composition and physical / mechanical properties, TempoCem Clear has been shown to be substantially equivalent to the predicate device.