Renamel® NANO™ +plus is a light-cure composite resin fabricated from multifunctional acrylic monomers and silicaceous fillers. These materials possess physical and mechanical properties that allow them to function in the oral cavity with esthetic qualities that mimic natural tooth appearance.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a dental resin material, Renamel® NANO™ +plus. It focuses on demonstrating substantial equivalence to a predicate device, Renamel® NANO™ (K070583), rather than presenting a study proving a device meets specific acceptance criteria in the context of an AI/human reader performance study.

Therefore, many of the requested details for an AI-medical device study (like sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document. This document primarily focuses on bench testing for physical and chemical properties and biocompatibility to demonstrate equivalence.

Here's a breakdown of the information that can be extracted and how it relates to the prompt, along with explanations for the information that is not available:

1. A table of acceptance criteria and the reported device performance:

The document provides a table comparing several physical and mechanical properties of the new device (Renamel® NANO™ +plus) against its predicate (Renamel® NANO™), including "Specification" which can be interpreted as the acceptance criteria for these properties based on ISO standards.

Property / Standard	Specification	Renamel®NANO™+plus Data (Reported Performance)	Renamel®Nano™ (Predicate Data)
Depth of cure (other than opaque materials)ISO 4049:2009; Type1, Class2, Group1	≥ 1.5mm	2.0 mm ± 0.2mm	2.0 mm ± 0.2mm
Flexural strengthISO 4049:2009; Type1, Class2, Group1	≥ 80 MPa	127 MPa ± 12 MPa	125 MPa ± 12 MPa
Water sorptionISO 4049:2009; Type1, Class2, Group1	≤ 40 µg/mm³	13.5 µg/mm³ ± 0.1 µg/mm³	21.2 µg/mm³ ± 0.1 µg/mm³
SolubilityISO 4049:2009; Type1, Class2, Group1	≤ 7.5 µg/mm³	0.0 µg/mm³ ± 0.05 µg/mm³	0.13 µg/mm³ ± 0.05 µg/mm³
RadiopacityISO 4049:2009; Type1, Class2, Group1	≥ 1mm	2.4 mm ± 0.2mm	2.7 mm ± 0.2mm
Compressive strength	≥ 300 MPa	360 MPa ± 36 MPa	367 MPa ± 36 MPa
Modulus of elasticity	≥ 7000 MPa	10475 MPa ± 1000 MPa	8925 MPa ± 900 MPa

Study Proving Device Meets Acceptance Criteria:

The study presented is a comparative laboratory testing of physical and mechanical properties and a toxicological evaluation to demonstrate biocompatibility. The purpose is to show substantial equivalence to an existing predicate device, not necessarily to meet a standalone clinical performance criterion for an AI system.

Information NOT available in the document (and why):

The following points are relevant for AI/Machine Learning medical device studies, which this document is not. Therefore, the information is not provided.

2. Sample sized used for the test set and the data provenance: This document describes bench testing of materials, not a study involving patient data or images with a test set of cases. The "sample size" would refer to the number of material specimens tested for each property, but this specific detail (e.g., n=X for flexural strength tests) is not explicitly stated. Data provenance (country, retrospective/prospective) is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established through standardized laboratory methods (e.g., ISO standards), not expert consensus from clinicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for the physical and mechanical properties is established through adherence to specified ISO standards (e.g., ISO 4049:2009) and other accepted laboratory testing methodologies for dental materials. For biocompatibility, it's based on toxicological evaluation and biocompatibility tests (10993-xx).
8. The sample size for the training set: Not applicable. This document is not about an AI/ML model needing training data.
9. How the ground truth for the training set was established: Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 24, 2017

Cosmedent, Inc Hiren Patel Director Of Regulatory Affairs 401 N Michigan Ave, Suite 2500 Chicago, Illinois 60611

Re: K163480

Trade/Device Name: Renamel Nano +plus Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: November 29, 2016 Received: December 12, 2016

Dear Hiren Patel:

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 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.

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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,

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name Renamel® NANO™ +plus

Indications for Use (Describe)

Renamel® NANOTM +plus is designed for,

Class I-V dental restorations
· Direct veneering of anterior teeth
· Splinting
· Repair of composite or ceramic restorations

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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			Section 5: 510(k) Summary
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Date Prepared:	12/21/2016
Company Name:	Cosmedent, Inc401 N Michigan Ave,Suite 2500,Chicago, IL, 60611Tel: 312-644-9586, Fax: 312-644-9752
Contact Person:	Hiren PatelDirector of Regulatory AffairsCosmedent, IncTel: 312-644-9586Email: hiren@cosmedent.com
Trade name:	Renamel® NANO™ +plus (NANO COMPOSITE)
Common Name:	Nano-Hybrid Dental Composite
Regulatory Class:	Class II
Device Panel:	Dental Panel
Regulation Number:	21 CFR 872.3690
Classification Name:	Tooth Shade Resin Material
Product Code:	EBF

Substantially Equivalent to:

The Renamel® NANO™ +plus is substantially equivalent to the Renamel® NANO™ (Cosmedent, Inc. K070583) cleared by FDA on April 16 2007.

Device Description:

Intended Use/Indication for Use:

Renamel® NANO™ +plus is designed for,

Class I-V dental restorations ●
Direct veneering of anterior teeth
Splinting
Repair of composite or ceramic restorations ●

Substantial Equivalence Summary

The mechanical properties, the intended use and the indication for use of Renamel® NANO™ +plus and its predicate: Renamel® NANO™ are the same. The compressive strength, flexural strength, depth of cure, particle size range and radiopacity of both composite materials fall within

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very similar values. The difference between Renamel® NANO™ and Renamel® NANO™ +plus can be found in chemical (formulation) and handling properties. These properties have a slight impact on the mechanical and physical properties of the composite material.

Property / Standard	Specification	Renamel®NANO™+plus	Renamel®Nano™(K070583)
Application properties/delivery form	---	Preloaded, plastic-screw fed syringe (5 grams),and individual unit dose compules (0.25 gram).The material is extruded directly (without tip)onto a suitable pad and placed in the preparedcavity and light cured.
Light curing wavelength	---	LED and Halogen light at wavelength range of400 - 500 nm.
Depth of cure (other thanopaque materials)ISO 4049:2009; Type1,Class2, Group1	≥ 1.5mm	2.0 mm± 0.2mm	2.0 mm± 0.2mm
Flexural strengthISO 4049:2009; Type1,Class2, Group1	≥ 80 MPa	127 MPa± 12 MPa	125 MPa± 12 MPa
Water sorptionISO 4049:2009; Type1,Class2, Group1	≤ 40 µg/mm³	13.5 µg/mm³± 0.1 µg/mm³	21.2 µg/mm³± 0.1 µg/mm³
SolubilityISO 4049:2009; Type1,Class2, Group1	≤ 7.5 µg/mm³	0.0 µg/mm³± 0.05 µg/mm³	0.13 µg/mm³± 0.05 µg/mm³
RadiopacityISO 4049:2009; Type1,Class2, Group1	≥ 1mm	2.4 mm± 0.2mm	2.7 mm± 0.2mm
Compressive strength	≥ 300 MPa	360 MPa± 36 MPa	367 MPa± 36 MPa
Modulus of elasticity	≥ 7000 MPa	10475 MPa± 1000 MPa	8925 MPa± 900 MPa

Table 5.1: Comparison of Renamel® NANO™ +plus / Renamel® NANO™ (K070583)

Substantial equivalent in Safety and efficacy (Biocompatibility)

The data analyzed from the toxicological evaluation of the new added components, and the results of the biocompatibility tests (10993-xx) substantiate that the Renamel® NANO™ +plus is safe and effective as the predicate Renamel® NANO™ (K070583).

Results/summary of the Substantial Equivalence

The subject device Renamel® NANO™ +plus has been compared with its predicate Renamel® NANO™ with regard to indication (intended use), performance data and chemical composition. In order to obtain better handling properties (stiffness and sculptability), the composition of the device has been modified. None of the new ingredients in the subject device poses any new concerns of safety and effectiveness, and comparison shows, that Renamel®NANO™+plus is substantially equivalent to the predicate Renamel®NANO™ (K070583).

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.