The Nanocomposite Restorative Kit consists of 2 types of nanocomposite restorative materials with a compatible bonding agent. The specific indications of each kit component are as follows:

Nanocomposite is indicated for:

Restorations of all cavity classes
Fabrication of direct inlays, onlays and indirect veneers
Core build-up after tooth preparation with the root canal post
Machinable Composite for Restorations
Indirect Inlays/Onlays

Nanocomposite Flowable is indicated for:

Small fillings of cavity classes III, IV and V
Minimally invasive fillings for deciduous teeth (all cavity classes)
Splinting of teeth

MDP One Bottle Bond is indicated for:

Bonding resin-based materials (especially light-cure composite / compomer materials) to tooth structure (dentin and enamel)

Device Description

The Nanocomposite Restorative Kit consists of 3 materials: Nanocomposite, Nanocomposite Flowable, and MDP One Bottle Bond.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies.

Based on the provided 510(k) summary, there is no detailed information regarding specific acceptance criteria, study designs, or reported device performance metrics in the way one would expect for a typical medical device performance study.

This 510(k) is an Abbreviated 510(k), which means the manufacturer is relying on conformity with recognized FDA guidance documents and demonstrating substantial equivalence to predicate devices rather than conducting extensive new clinical or standalone performance studies with defined acceptance criteria.

Therefore, the requested information elements (1-9) cannot be fully populated from this document. However, I can extract what is explicitly stated and explain why other information is absent.

Acceptance Criteria and Study Information (Based on Provided Text):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Abbreviated 510(k) and Guidance Docs)	Reported Device Performance (Implied)
Conformity with "Guidance for Industry and FDA Staff: Dental Cements - Premarket Notification (August 1998)"	The submission states "DMG-USA has provided information to demonstrate conformity with FDA's guidance document entitled Guidance for Industry and FDA Staff: Dental Cements - Premarket Notification (August 1998)." This implies that the device materials (Nanocomposite, Nanocomposite Flowable, MDP One Bottle Bond) meet the safety and performance requirements outlined in this guidance for dental cements aspects.
Conformity with "Guidance for Industry and FDA Staff: Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions (October 2005)"	The submission states "...and Guidance for Industry and FDA Staff: Dental Composite Resin Devices -Premarket Notification [510(k)] Submissions (October 2005)." This implies that the composite materials (Nanocomposite, Nanocomposite Flowable) meet the safety and performance requirements outlined in this guidance for dental composite resin devices.
Substantial Equivalence to Predicate Devices (Implied)	The conclusion states: "Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Nanocomposite Restorative Kit has been shown to be safe and effective for its intended use." This indicates that the device performs similarly in terms of safety and effectiveness to the identified predicate devices: - Nanocomposite: SternOmega Composite LC (K982692) - Nanocomposite Flowable: SternOmega Composite LC (K982692) - MDP One Bottle Bond: Clearfil tri-S bond (K042913)

2. Sample size used for the test set and the data provenance:

Not explicitly stated. For an Abbreviated 510(k) relying on guidance compliance and substantial equivalence, specific "test sets" with sample sizes like those for a novel clinical trial are typically not provided in the summary. Performance data often comes from bench tests and literature review, not new patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not stated. Ground truth establishment by experts in the context of clinical study data is not described here. This submission relies on technical characteristics and conformity to existing standards and predicate devices.

4. Adjudication method for the test set:

Not applicable/Not stated. Adjudication methods are relevant for studies involving human interpretation or clinical data, which are not detailed in this summary.

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:

No MRMC study was done. This device is a dental restorative material, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effect sizes are irrelevant.

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

Not applicable. This device is a physical restorative material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not explicitly stated in this summary for new data. For an Abbreviated 510(k) of a material, "ground truth" often refers to well-established material properties (e.g., bond strength, flexural strength, wear resistance, color stability) measured through standard laboratory tests, or the known performance and safety profiles of the predicate devices. The conformity to guidance documents implies that accepted methodologies for evaluating dental materials were followed.

8. The sample size for the training set:

Not applicable/Not stated. This is not an AI/machine learning device that would require a training set.

9. How the ground truth for the training set was established:

Not applicable/Not stated. As above, no training set for an algorithm is involved.

Summary of the Study (Implied by Abbreviated 510(k)):

The "study" refers to the documentation and data presented to FDA to demonstrate conformity to recognized guidance documents and substantial equivalence to legally marketed predicate devices.

Purpose: To demonstrate that the Nanocomposite Restorative Kit (Nanocomposite, Nanocomposite Flowable, and MDP One Bottle Bond) is safe and effective for its intended uses and is substantially equivalent to existing predicate devices.
Methodology: The submission is an Abbreviated 510(k). This approach involves:
- Providing information to demonstrate conformity with specific FDA guidance documents for dental cements and composite resin devices. These guidances typically outline the types of bench tests and characterization data expected for these materials (e.g., physical, mechanical, chemical properties, biocompatibility).
- Comparing the new device's technological characteristics and intended uses to those of predicate devices already on the market.
Data Provenance: The data primarily comes from bench testing done by the manufacturer or third-party labs to demonstrate conformity to standards and guidances. It also relies on the established safety and effectiveness profiles of the predicate devices. No clinical trial data or patient data source (e.g., country of origin, retrospective/prospective) is explicitly mentioned for new studies.
Results (Conclusion): "Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Nanocomposite Restorative Kit has been shown to be safe and effective for its intended use." This means the manufacturer successfully demonstrated that their new material performs comparably to the predicate devices and meets the requirements of the relevant FDA guidance documents.

Summary

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510(k) Summarv

		MAY 30 2008
Trade Name:	Nanocomposite Restorative Kit
Sponsor:	DMG USA, Inc.23 Frank Mossberg DriveAttleboro, MA 02703Registration # not yet assignedOwner/Operator No. 9005969
Device Generic Name:	Nanocomposite Restorative Kit
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II.

Product Description:

The Nanocomposite Restorative Kit consists of 3 materials:

Nanocomposite is indicated for

Restorations of all cavity classes .
. Fabrication of direct inlays, onlays and indirect veneers
Core build-up after tooth preparation with the root canal post .
. Machinable Composite for Restorations
. Indirect Inlays/Onlays

Nanocomposite Flowable is indicated for

. Small fillings of cavity classes III, IV and V
Minimally invasive fillings for deciduous teeth (all cavity classes) .
Splinting of teeth .

MDP One Bottle Bond is indicated for:

Bonding resin-based materials (especially light-cure composite / compomer . materials) to tooth structure (dentin and enamel)

Predicate Devices:

The components of the proposed Nanocomposite Restorative Kit materials are substantially equivalent to several currently marketed dental restorative materials including the following:

Nanocomposite:

Product Name	Predicates
SternOmega Composite LC	K982692 (Sterngold / Implamed)

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Nanocomposite Flowable:

Product Name	Predicates
SternOmega Composite LC	K982692 (Sterngold / Implamed)

MDP One Bottle Bond:

Product Name	Predicates
Clearfil tri-S bond	K042913 (Kuraray Medical inc.)

Safety and Performance:

This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), DMG-USA has provided information to demonstrate conformity with FDA's guidance document entitled Guidance for Industry and FDA Staff: Dental Cements - Premarket Notification (August 1998) and Guidance for Industry and FDA Staff: Dental Composite Resin Devices -Premarket Notification [510(k)] Submissions (October 2005).

Conclusion:

Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Nanocomposite Restorative Kit has been shown to be safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 30 2008

DMG USA, Incorporated C/O Ms. Pamela Papineau Regulatory Affairs Consultant Delphi Medical Device Consulting 5 Whitcomb Avenue Ayer, Massachusetts 01432

Re: K080480

Trade/Device Names: Nanocomposite Restorative Kit Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF and KLE Dated: May 5, 2008 Received: May 12, 2008

Dear Ms. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2- Ms. Papineau

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Chin Liu, Ph.D.

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5 May 2008 Nanocomposite Restorative Kit

Page

0:0011

510(k) Number (if known): K080480

Device Name: Nanocomposite Restorative Kit

Product Indications for Use:

The Nanocomposite Restorative Kit consists of 2 types of nanocomposite restorative materials with a compatible bonding agent. The specific indications of each kit component are as follows:

1. Nanocomposite is indicated for:
. Restorations of all cavity classes
Fabrication of direct inlays, onlays and indirect veneers .
Core build-up after tooth preparation with the root canal post .
Machinable Composite for Restorations .
Indirect Inlays/Onlays .
1. Nanocomposite Flowable is indicated for:
Small fillings of cavity classes III, IV and V D
Minimally invasive fillings for deciduous teeth (all cavity classes) ●
Splinting of teeth .
1. MDP One Bottle Bond is indicated for:
Bonding resin-based materials (especially light-cure composite / compomer . materials) to tooth structure (dentin and enamel)

Prescription Use	X
(Per 21 CFR 801 Subpart D)

Over-the-Counter Use
(Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off)
Division of Anesthesiology, General Hospital- Infection Control, Dental Devices
510(k) Number: K080486

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.