Identic and KromaFaze Alginate Dental Impression Materials

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image. The logo is simple and recognizable, conveying the department's authority and purpose. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 30, 2016 Kerr Corporation c/o Mr. Mohammad Ansari Regulatory Affairs Specialist Sybron Dental Specialties 1717 W. Collins Ave. Orange, California 92867 Re: K160441 Trade/Device Name: Identic and KromaFaze Alginate Dental Impression Materials Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 19, 2016 Received: May 23, 2016 Dear Mr. Ansari: 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. {1}------------------------------------------------ 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 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 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, Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K160441 ### Device Name Identic and KromaFaze Alginate Dental Impression Materials ### Indications for Use (Describe) Identic Alginate Dental Impression Materials are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or chectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. KromaFaze Alginate Dental Impression Materials are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or check their effectiveness. The device is intended to study and for production of restorative prosthetic devices, such as gold inlays and dentures. | Type of Use ( <i>Select one or both, as applicable</i> ) | | |----------------------------------------------------------|--| | | | |X Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) ## 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 Drug 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}------------------------------------------------ # 510(k) SUMMARY for Identic and KromaFaze Alginate Dental Impression Materials #### 1. Submitter Information: Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92867 | Contact Person: | Mohammad Saad Ansari | |-------------------|----------------------| | Telephone Number: | 909-962-5644 | | Fax Number: | 909-962-5694 | Date Prepared: June 22, 2016 #### 2. Device Name: | • | Proprietary Name: | Identic and KromaFaze Alginate Dental Impression<br>Materials | |---|----------------------|---------------------------------------------------------------| | • | Common Name: | Dental Impression Material | | • | Classification Name: | Impression Material | | • | CFR Number: | 872.3660 | | • | Device Class: | 2 | #### ELW . Product Code: #### 3. Predicate Device: The Identic Alginate and KromaFaze Alginate product lines are substantially equivalent to the legally marketed device Kromopan Impression Material (K121824) cleared on August 23, 2012, product code ELW. #### 4. Description of Device: Alginate impression materials are elastic, irreversible hydrocolloid impression materials made from seaweed. They are used to take primary or preliminary impressions of a patient's teeth and gums. Alginate impressions are taken to obtain diagnostic study models, which are the positive reproductions of the teeth and surrounding structures. Identic Alginate is cinnamon flavored and comes in three options - Regular Set, Fast Set, and Extra Fast Set. KromaFaze Alginate is mint flavored and comes in two options – Regular Set and Fast Set. KromaFaze Alginate has a color change feature that offers a visual guide for consistent impression making. {4}------------------------------------------------ | Accessories Used with<br>Identic and KromaFaze | Manufacturer of Accessory | |------------------------------------------------|-------------------------------------------------------------| | Impression Tray | DUX Dental<br>600 East Hueneme Road<br>Oxnard, CA 93033 USA | #### 5. Indications for Use: Identic Alginate Dental Impression Materials are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or check their effectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. KromaFaze Alginate Dental Impression Materials are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or check their effectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. #### Description of Safety and Substantial Equivalence: 6. ### Technological Characteristics The designs of Identic and KromaFaze Alginate are similar to the predicate Kromopan Impression Material (K121824), as they are all alginates used as general dental and orthodontic impression materials. They are all considered class II impression materials compliant to ISO 1563:1990 for Dental Elastic Impression Materials Part 2 Alginate dental impression material. Identic and KromaFaze are only different in the color changing feature and flavorings, otherwise the chemistry is equivalent. KromaFaze has a color change feature that provides visual indication and guide for impression making. ## Non-Clinical Performance Data Non-clinical performance data included testing for Work time, Dimensional Changes, Set Time, Mixing Time, Biodegradable Components, Derivatives, Dust Prevention, Mixing Ratio, Warm/Hard Water Setting, Cold Water Setting, Towel Wrap Dimensional Changes, Full Setting, Singles Mixing Ratio, Color & Scent, Smooth Surface, Gypsum Compatibility, Compressive Strength, Powder Uniformity, Homogeneous Material, Penetration Value, Elastic Recovery, Strain in Compression, Gypsum Cast Material, Color Change for KromaFaze, as well as Biocompatibility and Stability testing. Following the assessment route in ISO 10993-1:2009 Biological Evaluation of Medical Devices, Annex A, Biocompatibility testing was performed at a third party laboratory and testing results proved the proposed Identic and KromaFaze Alginate Impression met the biocompatibility requirement. The following standards were utilized for the non-clinical performance testing: - . Guidance for Industry and FDA Staff: Dental Impression Materials - Premarket Notification [510(k)] Submissions, August 17, 1998 - ISO 1563:1990 for Dental Elastic Impression Materials part 2 Alginate dental ● {5}------------------------------------------------ impression material - ISO 10993-1: 2009 Biological evaluation of medical devices . - ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in . Vitro Cytotoxicity | Element | Predicate<br>Kromopan | Proposed<br>Identic Alginate | Proposed<br>KromaFaze Alginate | |-----------------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) | K121824 | To be assigned | To be assigned | | Trade Name | Kromopan | Identic Alginate | KromaFaze Alginate | | Target Users | Licensed dental<br>professionals | Licensed dental<br>professionals | Licensed dental<br>professionals | | Device Description | Kromopan is an elastic,<br>irreversible hydrocolloid<br>impression material. | Identic Alginate is an<br>elastic irreversible<br>hydrocolloid impression<br>material | KromaFaze Alginate is an<br>elastic irreversible<br>hydrocolloid impression<br>material | | Common Name | Alginate Impression<br>Material | Alginate Impression<br>Material | Alginate Impression<br>Material | | Classification Name | Impression Material,<br>Dental | Impression Material,<br>Dental | Impression Material,<br>Dental | | Class | 2 | 2 | 2 | | Product Code | ELW | ELW | ELW | | Storage | Store at room<br>temperature. | Store at room<br>temperature. | Store at room<br>temperature. | | Setting Mechanism | Reaction of alginates and<br>calcium sulfate with<br>water | Reaction of alginates and<br>calcium sulfate with<br>water | Reaction of alginates and<br>calcium sulfate with<br>water | | Color Change | Yes | No | Yes | | Material Compatibility | Unknown | Biocompatibility meets<br>requirements | Biocompatibility meets<br>requirements | | Shelf Life | 60 months based on real<br>time data | 24 months based on real<br>time data | 24 months based on real<br>time data | | Mixing time per ISO<br>1563 | Type I = 1'45"<br>Type II = 2'45" | Pass 30" | Pass 30" | | Working time per ISO<br>1563 | Type I = 1'45"<br>Type II = 2'45" | Pass 2'20"<br>(Regular Set) | Pass 2'20"<br>(Regular Set) | | | | Pass 1'45"<br>(Fast Set) | Pass 1'45"<br>(Fast Set) | | | | Pass 1'15"<br>(Extra Fast Set) | | | Setting time per ISO<br>1563 | 30" | Pass ≤3'30"<br>(Regular Set) | Pass ≤3'30"<br>(Regular Set) | | | | Pass ≤2'20"<br>(Fast Set) | Pass ≤2'20"<br>(Fast Set) | | Element | Predicate<br>Kromopan | Proposed<br>Identic Alginate | Proposed<br>KromaFaze Alginate | | Homogeneous Mixed<br>Material ISO 1563 | Unknown | Pass ≤2'00"<br>(Extra Fast Set)<br>Pass | Pass | | Compatibility with<br>gypsum and<br>reproduction of detail<br>(μm) ISO 1563 | Type I = 20<br>Type II = 20 | Imparts a smooth surface<br>to, and separates cleanly<br>from, a gypsum cast.<br>Impression reproduces 50<br>µm line.<br>Pass | Imparts a smooth surface<br>to, and separates cleanly<br>from, a gypsum cast.<br>Impression reproduces 50<br>µm line.<br>Pass | | Recovery from<br>deformation (%) per<br>ISO 1563 | 95.5 | ≥95%<br>Pass | ≥95%<br>Pass | | Strain in compression<br>ISO 1563 | Unknown | Between 5% and 20%<br>Pass | Between 5% and 20%<br>Pass | | Compressive strength<br>per ISO 1563 | Unknown | ≥0.35 MPa<br>Pass | ≥0.35 MPa<br>Pass | | Dimensional Changes<br>at 100 hours | 100 hours | Pass<br>≤ 2% when compared to a<br>mold | Pass<br>≤ 2% when compared to a<br>mold | | Configurations/Dimen<br>sions | Carton box containing<br>20x450g bags (9 kg.) | 1 lb. (454 g) bag and a<br>singles pack of 18 g | 1 lb. (454 g) bag and a<br>singles pack of 18 g | | Method of Mixing | Mixing of powder with<br>water | Mixing of powder with<br>water | Mixing of powder with<br>water | | Flow Properties | Unknown | N/A as the material is a<br>powder that sets upon<br>mixing with water. The<br>property does not apply<br>to Alginates, only to<br>impression pastes. | N/A as the material is a<br>powder that sets upon<br>mixing with water. The<br>property does not apply<br>to Alginates, only to<br>impression pastes. | | Viscosity | Unknown | Not Applicable; as the<br>material is a powder that<br>sets upon mixing with<br>water. Viscosity property<br>does not apply to<br>Alginates, only<br>impression pastes. | Not Applicable; as the<br>material is a powder that<br>sets upon mixing with<br>water. Viscosity property<br>does not apply to<br>Alginates, only<br>impression pastes. | | Wettability | Unknown | N/A as the material is a<br>powder that sets upon<br>mixing with water. The<br>property does not apply<br>to Alginates, only to<br>impression pastes. | N/A as the material is a<br>powder that sets upon<br>mixing with water. The<br>property does not apply<br>to Alginates, only to<br>impression pastes. | | Working Humidity | Unknown | Working/Setting Time<br>per ISO 1563 is tested in<br>humidity chamber at<br>release | Working/Setting Time<br>per ISO 1563 is tested in<br>humidity chamber at<br>release | Table 5.1: Predicate and Proposed Device Comparison Table {6}------------------------------------------------ {7}------------------------------------------------ ### Clinical Performance Data Clinical performance testing has not been performed for Identic and KromaFaze Alginate Dental Impression Materials. ### Intended Use The Intended Use for Identic and KromaFaze Alginate Dental Impression Materials is identical to the predicate, Kromopan (K121824). Identic and KromaFaze Alginate Dental Impression Materials are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or check their effectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. ### Conclusion as to Substantial Equivalence The technological characteristics of Identic and KromaFaze Alginate are very similar to the predicate, Kromopan (K121824). The intended uses of the proposed and predicate products are similar. The only major differences between KromaFaze and Identic are in a color changing feature and flavorings. These proposed products have an equivalent chemical principle of function, setting mechanism, and have similar delivery systems as compared to the predicate. The proposed and predicate products also share similarities in mechanism of action, preparation times, and select performance characteristics relevant to impression materials. The proposed Identic and KromaFaze Alginate Impression Materials are substantially equivalent to the predicate device Kromopan Impression Material (K121824) based on the design, performance, biocompatibility testing, and the intended use. Known differences between the proposed product and predicate device include shelf life, mixing times, working times, and setting times. Any noted differences in technological characteristics between the proposed and predicate products do not affect the intended use, do not raise new questions of safety and effectiveness, and demonstrate the proposed product is at least as safe and effective as the legally marketed predicate device. Based on this reasoning and the results of performance testing based on ISO 1563:1990 and biocompatibility testing, Identic and KromaFaze Alginate is substantially equivalent to the predicate, Kromopan Impression Material (K121824).