Renamel® Microfill is light-cured, microfilled, highly polishable dental restorative material. According to the applicable FDA recognized consensus standard ISO 4049 - "Dentistry -Polymer-based restorative materials", this device is classified as Type 1, Class 2, Group 1: Polymer-based restorative materials, involving occlusal surfaces, which uses external energy source for intra-orally curing. Renamel® Microfill consists of multi-functional acrylic Resin and fillers of 0.04 - 0.2 micron sized particles of inorganic and prepolymerized composite (70% by weight, 60% by volume). These devices possess physical and mechanical properties that allow them to function in the oral cavity with esthetic quality that mimics natural enamel surface.

AI/ML Overview

This document describes the premarket notification for the Renamel® Microfill dental restorative material. The acceptance criteria and supporting study details are primarily focused on the physical and mechanical properties of the material, demonstrating its substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance:

Property / Standard	Specification (Acceptance Criteria)	Renamel® Microfill Performance (Reported Device Performance)
Depth of cure (other than opaque materials) ISO 4049:2009; Type1, Class2, Group1	≥ 1.5mm	2.15 mm ± 0.1mm
Flexural strength ISO 4049:2009; Type1, Class2, Group1	≥ 80 MPa	95.5 MPa ± 3 MPa
Water sorption ISO 4049:2009; Type1, Class2, Group1	≤ 40 µg/mm³	15 µg/mm³ ± 0.5 µg/mm³
Solubility ISO 4049:2009; Type1, Class2, Group1	≤ 7.5 µg/mm³	0.9 µg/mm³
Radiopacity ISO 4049:2009; Type1, Class2, Group1	≥ 1mm (Not claimed by applicant)	None (not claimed)
Compressive strength	≥ 320 MPa	410 MPa ± 40 MPa
Modulus of elasticity	≥ 3000 MPa	5100 MPa ± 300 MPa

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size used for each specific test (e.g., number of specimens for depth of cure, flexural strength, etc.). However, it does refer to the ISO 4049:2009 standard for testing polymer-based restorative materials, which would inherently dictate the sample sizes required for statistically sound testing. The data provenance is not specified, but it can be inferred that these are in-house laboratory tests conducted by Cosmedent, Inc. or a contracted testing facility to comply with the referenced ISO standard. The data is retrospective in the context of this submission, meaning the tests were performed before the submission to demonstrate compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable to this document. The "ground truth" for the performance criteria of a dental restorative material is established through objective, standardized physical and mechanical property testing according to international standards (ISO 4049). It does not involve expert consensus in the same way clinical diagnostic studies might.

4. Adjudication Method for the Test Set:

This information is not applicable to this document. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For material property testing, the results are typically quantitative measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable to this document. MRMC studies are relevant to diagnostic devices involving human interpretation of medical data, often with AI assistance. This document pertains to a dental restorative material, which is not a diagnostic device and does not involve "human readers" in the context of interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable to this document. This refers to the performance of an AI algorithm independently. The Renamel® Microfill is a physical dental material, not an AI algorithm.

7. The Type of Ground Truth Used:

The ground truth used for demonstrating compliance is based on objective, quantitative measurements of physical and mechanical properties derived from standardized laboratory tests as defined by ISO 4049:2009 and other general material testing standards (e.g., for compressive strength and modulus of elasticity). This is equivalent to established scientific and engineering standards for material performance.

8. The Sample Size for the Training Set:

This information is not applicable to this document. "Training set" refers to data used to train machine learning models. The Renamel® Microfill is a physical product, and its development and testing do not involve machine learning training in this context.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the same reason as point 8.

Summary

{0}------------------------------------------------

December 5, 2017

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Cosmedent, Inc Mary Nowak Vice President Development & Regulatory Affairs 401 N. Michigan Ave, Suite 2500 Chicago, Illinois 60611

Re: K172707

Trade/Device Name: Renamel® Microfill Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: September 5, 2017 Received: September 8, 2017

Dear Mary Nowak:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

{1}------------------------------------------------

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows the name "Mary S. Runner -S" in a simple, sans-serif font. The text is black against a white background. The letters are evenly spaced and easily readable.

For Tina Kiang, Ph.D. 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}------------------------------------------------

Indications for Use

510(k) Number (if known) K172707

Device Name Renamel® Microfill

Indications for Use (Describe)

Renamel® Microfill is designed for,

· Direct anterior veneers
· Anterior Class III and IV restorations
· Class V restorations (cervical caries, root erosion, wedge-shaped defects)
· Closing of diastemas
· Repair of composite and ceramic veneers
Top layer of Class I and II restorations

Type of Use (Select one or both, as applicable)
Residential Use (Part 1, CFR 201.2, Subpart B)
Care-Type Supportive Use (24 CFR 201.2, Subpart C)

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}------------------------------------------------

Section 5: 510(k) Summary K172707

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92

Date Prepared:	12/01/2017
501(k) Submitter:	Cosmedent, Inc.401 N Michigan Ave,Suite 2500,Chicago, IL, 60611Tel: 312-644-9586, Fax: 312-644-9752
Contact Person:	Gary ChuvenDirector of Regulatory AffairsCosmedent, Inc.Tel: 312-644-9395 ext. 117Email: gary@cosmedent.com
Trade Name:	Renamel® Microfill (Composite)
Common Name:	Light-Cured Dental Restorative Composite
Regulatory Class:	Class II
Device Panel:	Dental Panel
Regulation Number:	21 CFR 872.3690
Classification Name:	Tooth Shade Resin Material
Product Code:	EBF

Description of Device:

Intended Use:

Renamel® Microfill is intended to be used to create lifelike dental restoration.

Indications for Use:

Renamel® Microfill is designed for,

Direct anterior veneers
Top layer of Class I and II restorations

{4}------------------------------------------------

Anterior Class III and IV restorations ●
Class V restorations (cervical caries, root erosion, wedge-shaped defects)
Closing of diastemas
Repair of composite and ceramic veneers

Substantial Equivalence Discussion:

Intended Use/ Indication for Use

Subject Renamel® Microfill lists the specific indication for use to provide better understanding to the healthcare professional. The original statement in PMN K854755 was considered insufficiently specific. Specifying the indications for use does not add any new safety and effectiveness concerns. Also, it does not change the intended use, "to create lifelike dental restorations."

Chemical Composition

Chemical composition of the subject Renamel® Microfill and predicate Renamel® Composite Resin is somewhat different. The changes in the chemical composition are to comply with the requirements of the ISO 4049 Type 1 Class 2 Group 1 standards with similar handling and polishing properties. The predicate device does not achieve the necessary flexural strength values for Type 1 restorative materials. In addition, subject Renamel® Microfill has more shades for dental restoration and a new single use package (Compule). Neither the changes in the chemical composition nor the new single use package of the subjected Renamel® Microfill add any new concerns of safety.

The table below depicts the modification associated with Renamel® Microfill and Renamel® Composite Resin (K854755).

Property / Standard	Specification	Renamel® Microfill	Renamel® CompositeResin (K854755)
Application properties/delivery form	---	Preloaded, plastic-screwfed syringe (4 grams),and individual unit dosecompules (0.20 gram).The material is extrudeddirectly (without tip) ontoa suitable pad and placedin the prepared cavity andlight cured.	Preloaded, plastic-screw fed syringe (2.5grams). The material isextruded directly(without tip) onto asuitable pad and placedin the prepared cavityand light cured.
Intended use	---	Intended to be used tocreate lifelike dentalrestoration.	Intended to be used tocreate lifelike dentalrestoration.
Indication for Use	---	Renamel® Microfill isdesigned for,Direct anterior veneers Top layer of Class I and II restorations Anterior Class III and IV restorations Class V restorations(cervical caries, rooterosion, wedge-	---

Table 5.1: Predicate Renamel® Resin Composite and Proposed Renamel® Microfill

{5}------------------------------------------------

Property / Standard	Specification	Renamel® Microfill	Renamel® CompositeResin (K854755)
		shaped defects) Closing of diastemas Repair of composite and ceramic veneers
Light curing wavelength	---	LED and Halogen light at wavelength range of 400 – 500 nm.
Depth of cure (other than opaque materials) ISO 4049:2009; Type1, Class2, Group1	≥ 1.5mm	2.15 mm± 0.1mm	2.0 mm± 0.1mm
Flexural strength ISO 4049:2009; Type1, Class2, Group1	≥ 80 MPa	95.5 MPa± 3 MPa	76 MPa± 4 MPa
Water sorption ISO 4049:2009; Type1, Class2, Group1	≤ 40 µg/mm³	15 µg/mm³± 0.5 µg/mm³	12.5 µg/mm³± 0.5 µg/mm³
Solubility ISO 4049:2009; Type1, Class2, Group1	≤ 7.5 µg/mm³	0.9 µg/mm³	1.1 µg/mm³
Radiopacity ISO 4049:2009; Type1, Class2, Group1	≥ 1mm	None(not claimed)	None(not claimed)
Compressive strength	≥ 320 MPa	410 MPa± 40 MPa	390 MPa± 30 MPa
Modulus of elasticity	≥ 3000 MPa	5100 MPa± 300 MPa	4575 MPa± 440 MPa

Substantial equivalent in Safety (Biocompatibility)

Biocompatibility studies were performed on the subject Renamel® Microfill. The data were analyzed and the results of the biocompatibility tests (ISO10993-1, ISO10993-2, ISO10993-5, ISO10993-10, & ISO10993-11) substantiate that Renamel® Microfill with its modification in composition is as safe (biocompatible) as the predicate Renamel® Composite Resin.

Conclusion:

The subject device Renamel® Microfill has been compared with its predicate Renamel® Composite Resin with regards to intended use, performance data and chemical composition. In order to provide compliance with ISO 4049 Type 1 Class 2 (Class I&II restorations), the composition of the device has been modified. None of the new ingredients (pigments, polyacrylic resin) in the subject device poses any new concerns of safety and effectiveness, and comparison shows, that Renamel® Microfill is substantially equivalents to the predicate Renamel® Composite Resin (K854755).

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.