FORMA Composite (Shade A3D)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font. March 15, 2024 Ultradent Products, Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059 Re: K240694 Trade/Device Name: FORMA Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF Dated: March 12, 2024 Received: March 14, 2024 Dear Dave Yungvirt: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Michael E. Adjodha -S Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K240694 Device Name FORMA Composite | Indications for Use (Describe) | FORMA Composite is designed for restorations in anterior and posterior teeth. | |--------------------------------|-------------------------------------------------------------------------------| |--------------------------------|-------------------------------------------------------------------------------| Type of Use (Select one or both, as applicable) | <label> <input checked="checked" type="checkbox"/> Remediation Use (Part 21 CFR 221, Subpart D) </label> | |---------------------------------------------------------------------------------------------------------------| | <label> <input type="checkbox"/> Cosmetic Use (21 CFR 221, Subpart C) </label> | > 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}------------------------------------------------ Ultradent Products, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 Est. Reg. No. 1718912 #### 510(k) Summary This summary of the 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 FORMA Composite. ## I. Applicant's Name and Address Ultradent Product, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 | Contact Person: | Adam Black | |------------------------|-------------------------------------| | Title: | Senior Manager - Regulatory Affairs | | Telephone: | 801-553-4425 | | Email: | adam.black@ultradent.com | | Date Summary Prepared: | March 11, 2024 | #### II. Name of the Device | Device: | FORMA Composite | |--------------------|-----------------------------| | Trade/Device Name: | FORMA Composite (Shade A3D) | | Common Name: | Tooth Shade, Resin | | Review Panel: | Dental | | Regulation Number: | 21 CFR 872.3690 | | Device Class: | Class II | | Product Code(s): | EBF | ## III. Device Description FORMA™ Composite is a Bis-GMA-based restorative composite. FORMA™ composite is designed for restorations in anterior and posterior teeth and is suitable for occlusal surfaces. Its formula contains a zirconia/silica inorganic filler combination and barium glass. FORMA™ composite is shaded based on the VITA shade guide, and is radiopaque. FORMA™ composite has a radiopacity value greater than 2 mm of aluminum has a radiopacity equivalent to that of dentin. Thus, 1 mm of material having a radiopacity equivalent to 1 mm of aluminum has a radiopacity equivalent to that of dentin and 2 mm of aluminum is equivalent to enamel. FORMA™ composite A3D is filled 78% w/w. FORMA™ composite is a nanohybrid composite with nanoparticles entombed within the composite's formulation. {4}------------------------------------------------ Ultradent Products, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 Est. Reg. No. 1718912 #### IV. Statement of Intended Use FORMA™ Composite is used for direct and indirect restorations in both the anterior and posterior regions. #### V. Predicate Device Predicate Identified: Mosaic Universal Composite K151094 ## VII. Comparison of Technological Characteristics #### Predicate technological comparison: The predicate and subject device have the same technological characteristics, which is primarily the design as a light-curable dental composite material which is available in a reusable syringe and single-use capsule presentation. The primary difference between the subject and predicate device is in the chemical composition which was adjusted for handling and shading. These differences and similarities have been evaluated below in Table 1: #### Table 1 | Descriptive<br>Information | Subject Device: FORMA Composite | Predicate: Mosaic Universal<br>Composite (K151094) | Explanation of<br>Differences | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | EBF | EBF | N/A – Identical product<br>code | | Indications for<br>Use | FORMA™ Composite is used for<br>direct and indirect restorations in<br>both the anterior and posterior<br>regions. | Mosaic composite is used for direct<br>and indirect restorations (inlays,<br>onlays, and veneers) in both the<br>anterior and posterior regions. | The removal of the<br>examples of indirect<br>restoration types "inlays,<br>onlays, and veneers" does<br>not impact the safety or<br>performance as this<br>information was only to<br>provide small<br>clarification. | | Principle of<br>Operation | Mechanical leverage is used to<br>express composite. The unique<br>chemical structure of FORMA | Mechanical leverage is used to<br>express composite. The unique<br>chemical structure of Mosaic allows | N/A – Identical principles<br>of operation | | Descriptive<br>Information | Subject Device: FORMA Composite | Predicate: Mosaic Universal<br>Composite (K151094) | Explanation of<br>Differences | | | Composite allows for the chemistry<br>to be placed into preformed<br>cavities in the tooth structure to<br>rebuild the physical structure of the<br>removed dentin. The formulation<br>contains photoinitiators that cause<br>polymerization of the moldable<br>chemistry. Once the device is<br>polymerized, it exhibits mechanical<br>and physical behaviors similar to<br>that of natural dentition. | for the chemistry to be placed into<br>preformed cavities in the tooth<br>structure to rebuild the physical<br>structure of the removed dentin. The<br>formulation contains photoinitiators<br>that cause polymerization of the<br>moldable chemistry. Once the device<br>is polymerized, it exhibits<br>mechanical and physical behaviors<br>similar to that of natural dentition. | | | Intended User | Dentist or dental professional | Dentist or dental professional | N/A – Identical Intended<br>User | | Delivery System | 4g Reusable Syringe or 0.2g single-<br>use capsule | 4g Reusable Syringe or 0.2g single-<br>use capsule | N/A – Identical delivery<br>system offerings | | Composition of<br>Materials | Bis-GMA, TEGDMA, Bis-EMA, and<br>UDMA base<br>Photoinitiators (Camphorquinone)<br>Silanated Glass<br>Silica | Bis-GMA, TEGDMA, UDMA base<br>Photoinitiators (Camphorquinone)<br>Silanated Glass<br>Silica | Similar – Base material<br>has been adjusted for<br>handling and to achieve<br>proper shade. | | Physical<br>Properties | Depth of Cure ≥1.5mmCurable wavelength 385-<br>515nmCuring Intensity ≥800 mW/cm²Curing Time 10s per layer, 20s<br>final cureFlexural Strength ≥80 MPaFiller particle size 0.014-3µmWater sorption ≤40 µg/mm³Water solubility ≤7.5 µg/mm³Radio-Opacity ≥1mm of AlSurface Hardness ≥50.0 HK | Depth of Cure ≥1.5mmCurable wavelength 385-515nmCuring Intensity ≥800 mW/cm²Curing Time 10s per layer, 20s<br>final cureFlexural Strength ≥80 MPaFiller particle size* ≥0.02µmWater sorption ≤40 µg/mm³Water solubility ≤7.5 µg/mm³Radio-Opacity ≥1mm of AlSurface Hardness ≥50.0 HK | Similar – ISO 4049<br>Compliant | | FDA Recognized<br>Standards | ISO 7405: 2018<br>ISO 4049:2019<br>IEC 62366-1:2020<br>ISO 14971:2019<br>ISO 10993-1:2018<br>ISO 15223-1:2021<br>ISO 7491-2000 | ISO 7405: 2018<br>ISO 4049:2009<br>IEC 62366-1:2015<br>ISO 14971:2012<br>ISO 10993-1:2018<br>ISO 7491:2000 | Similar – Addition of ISO<br>15223-1 based on use of<br>symbols | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the address and contact information for Ultradent Products, Inc. The address is 505 West Ultradent Drive (10200 South), South Jordan, UT 84095. The establishment registration number is 1718912. The image also includes the Ultradent logo. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the Ultradent Products, Inc. logo and company information. The logo is an orange square with the letters "UP" in white. Below the logo is the word "ULTRADENT" in white. The company address is listed as "lent Drive (10200 South) South Jordan, UT 84095". 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 Est. Reg. No. 1718912 # VIII Non-Clinical Performance Testing: Verification and validation testing was performed to show that the subject device is substantially equivalent to the currently marketed predicate device, Mosaic Universal Composite. Full testing to ISO 4049:2019, surface hardness evaluation, drop test ship testing, and an assessment on the curing wavelength, curing intensity and curing time were completed for the product verification testing. Simulated use and validation testing was conducted by dental professionals to confirm that all aspects from usability assessments and risk management were implemented in the labeling and the design of the device itself. The conclusion of this validation testing confirmed that the subject device met the predefined user needs and the indications for use, which are identical to the predicate device. Thus the verification and validation support the conclusion that the subject device, FORMA Composite, is substantially equivalent to the predicate device, Mosaic Universal Composite (K151094). ## IX Biocompatibility Assessment FORMA Composite has been evaluated for applicable biological risks associated to the device type according to ISO 7405:2018 and ISO 10993-1:2018. Cytotoxicity, Sensitization, and Irritation tests were conducted according to applicable ISO 10993 series standards. Other applicable biological endpoints (Systemic Toxicity, Implantation Effects, and Genotoxicity) were evaluated utilizing available literature, chemical characterization testing and other biocompatibility tests available for the device and its constituents. ## Conclusion: The predicate and subject devices have identical indications for use with a slight variation to remove the examples of indirect restoration types. The differences between the predicate and subject device have been evaluated with established methods, including testing to ISO 4049, biological risk evaluations according to ISO 10993-1, and product packaging assessments. Based on the testing and evaluation of the subject device, FORMA Composite, as compared to the predicate device, Mosaic Universal Composite (K151094), the conclusion can be made that FORMA Composite is substantially equivalent to the predicate device.