bonding chemically cured, light cured, or dual cured resin-based materials e. g. composite, compomer, ormocer materials to tooth structure (dentin and enamel)
treatment of hypersensitive teeth .

Composite Repair MMA-free is indicated

as a bonding agent for the intra- or extraoral repair of poor or damaged resin-based materials restorations
as a bonding agent for composite-based posts .
for shade corrections of esthetically unsatisfying restorations .
for repair and completion of temporary crowns and bridges .
as a bonding agent on resin-based materials .

PrimaFlow is indicated for

minimally invasive restorations
Class III and V restorations .
bases .
extended fissure sealing
restorations of all classes of cavities in deciduous teeth .
as a temporary luting cement for e.g. veneers, and .
as a flowable compomer repair agent .

Flowable Composite (LuxaFlow) is indicated as

as an aesthetic anterior restoration .
a base restoration under posterior or anterior composites .
an add-on or repair material for provisional crowns & bridges .
for incorporation of most mechanically anchored attachment components into the acrylic base of an overdenture or partial denture.
as a temporary luting cement for e.g. veneers, and .
as a flowable composite repair agent . .

Device Description

The Composite/Compomer Repair Kit consists of 4 materials:

1. A general 6" generation bonding agent for enamel and dentin,
1. A special bonding agent for resin-based materials in general, i. e. composites, compomers, and ormocers,
1. A flowable compomer and
1. A flowable composite

AI/ML Overview

The provided document is a 510(k) summary for a "Composite/Compomer Repair Kit." It describes the device's indications for use and claims substantial equivalence to predicate devices, but it does not contain information about acceptance criteria, a specific study proving the device meets these criteria, or any performance metrics (e.g., sensitivity, specificity, accuracy) that would be presented in a table.

The document states that the submission is an Abbreviated 510(k) and refers to FDA guidance documents for dental composites, implying that the safety and performance were established by demonstrating conformity with these guidelines and substantial equivalence to existing devices. However, the details of those demonstrations are not included here.

Therefore, I cannot fulfill your request for the specific points related to acceptance criteria and the study that proves the device meets them because that information is not present in the provided text.

Based on the information given, I can only state the following:

A table of acceptance criteria and the reported device performance: Not provided in the document. The document primarily focuses on establishing substantial equivalence to predicate devices.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided in the document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the document.
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 relevant and not provided. This device is a dental material, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant and not provided. This device is a dental material, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided in the document.
The sample size for the training set: Not relevant and not provided. This device is a dental material, not an AI model.
How the ground truth for the training set was established: Not relevant and not provided. This device is a dental material, not an AI model.

The document concludes that the device is "safe and effective for its intended use" based on "indications for use, technological characteristics, and comparison to the predicate devices." This implies that the 'study' conducted was likely a comparison of material properties and performance against established standards and predicate devices, rather than a clinical trial with specific performance metrics against a ground truth.

To answer your prompt, I would need a different type of document, typically one that details a clinical study or a comprehensive performance evaluation with specific endpoints and acceptance criteria.

Summary

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04196

AUG 3 0 2004 Attachment K 510(k) Summary

Trade Name:	Composite/Compomer Repair Kit
Sponsor:	DMG USA, Inc.414 South State StreetDover, DE 19901Registration # not yet assignedOwner/Operator No. 9005969
Device Generic Name:	Dental restorative material and bonding agent
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II.

Predicate Devices:

The proposed DMG-USA Composite/CompomerKit restorative material is substantially equivalent to several currently marketed dental restorative materials:

Product Name	510(k) #	Manufacturer
PrimaFlow	K002086	DMG USA
Zenith Flowable Composite	K970683	Foremost Dental Mfg.
Composite Repair	K992879	DMG-Hamburg
Clearfill Repair	K001914	Kuraray Co., Ltd.
PermaCem	K012316	DMG USA
LuxaCore/uxaCore Dual	K012307	DMG USA
Solobond Plus	K003153	Voco
Tag Bong	K845033	Foremost Dental Mfg.
Xeno III	K023776	Dentsply
iBond	K022612	Heraeus Kulzer

Product Description/Indications for Use:

The Composite/Compomer Repair Kit consists of 4 materials:

1. A general 6" generation bonding agent for enamel and dentin,
1. A special bonding agent for resin-based materials in general, i. e. composites, compomers, and ormocers,
1. A flowable compomer and
1. A flowable composite

Bonding System is indicated for

. bonding chemically cured, light cured, or dual cured resin-based materials e. g. composite, compomer, ormocer materials to tooth structure (dentin and enamel)
treatment of hypersensitive teeth .

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

Composite Repair MMA-free is indicated

as a bonding agent for the intraoral repair of poor or damaged resin-based . materials composite restorations
. as a bonding agent for composite-based posts
. for shade corrections of esthetically unsatisfying restorations
for repair and completion of temporary crowns and bridges .
. as a bonding agent on resin-based materials

PrimaFlow is indicated for

minimally invasive restorations .
Class III and V restorations
. bases
. extended fissure sealing
restorations of all classes of cavities in deciduous teeth .
as a temporary luting cement for e.g. veneers, and .
. as a flowable compomer repair agent .

Flowable Composite is indicated as

as an aesthetic anterior restoration .
a base restoration under posterior or anterior composites .
. an add-on or repair material for provisional crowns & bridges
. for incorporation of most mechanically anchored attachment components into the acrylic base of an overdenture or partial denture.
. as a temporary luting cement for e.q. veneers, and
. as a flowable composite repair agent .

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 quidance document entitled Guidance for Industry and FDA Staff: Dental Composites -Premarket Notification (November 1998).

Conclusion:

Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Composite/Compomer Repair Kit restorative materials have been shown to be safe and effective for its intended use.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 0 2004

Ms. Pamela Papineau, RAC Consultant DMG USA, Incorporated 414 South State Street Dover, Delaware 19901

Re: K041960

Trade/Device Name: Composite/Compomer Repair Kit Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE and EBF Dated: June 15, 2004 Received: July 21, 2004

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.

{3}------------------------------------------------

Page 2 – Ms. Pamela Papineau, RAC

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase be advisod that 1 27 × ination that your device complies with other requirements of the Act or that I Dri has mude a acternilations 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); an the Act 3 requirements) increased and manufacturing practice requirements as set forth in the quality fabething (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) rins letter will acation. The FDA finding of substantial equivalence of your device to a legally premaince notification - 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 rr you active of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, andraa votabling ogy and in
please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

"Chiu S. Lin, PhD 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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Page of

510(k) Number (if known): K041960

Device Name: Composite/Compomer Repair Kit

Indications for Use:

The Composite/Compomer Repair Kit consists of 4 materials:

1. a general 6th generation bonding agent for enamel and dentin,
1. a special bonding agent for resin-based materials in general, i. e. composites, compomers, and ormocers,
1. a flowable compomer and
1. a flowable composite

Bonding System (Contax) is indicated for

bonding chemically cured, light cured, or dual cured resin-based . materials e. g. composite, compomer, ormocer materials to tooth structure (dentin and enamel)
treatment of hypersensitive teeth .

Composite Repair MMA-free is indicated

as a bonding agent for the intra- or extraoral repair of poor or damaged . resin-based materials restorations
as a bonding agent for composite-based posts .
for shade corrections of esthetically unsatisfying restorations .
for repair and completion of temporary crowns and bridges .
as a bonding agent on resin-based materials .

PrimaFlow is indicated for

minimally invasive restorations �
Class III and V restorations .
bases .
extended fissure sealing ●
restorations of all classes of cavities in deciduous teeth .
as a temporary luting cement for e.g. veneers, and .
as a flowable compomer repair agent .

2 Page of

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

Flowable Composite (LuxaFlow) is indicated as

as an aesthetic anterior restoration .
a base restoration under posterior or anterior composites .
an add-on or repair material for provisional crowns & bridges .
for incorporation of most mechanically anchored attachment . components into the acrylic base of an overdenture or partial denture.
as a temporary luting cement for e.g. veneers, and .
as a flowable composite repair agent . .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the -Counter Use (21 CFR 807 Subpart D)

Suresh Kumar

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D

510(k) Number. K941640

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.