SA Flowable Composite is a self-adhesive, light-curing, flowable composite with optimum consistency for the described indications. The radiopaque composite is immediately ready for use because the preparatory steps of etching, priming and bonding are unnecessary. The SA Flowable Composite will be supplied in convenient applicators.

AI/ML Overview

This is a 510(k) summary for a dental resin material, not an AI/ML device. Therefore, many of the requested categories related to AI performance, ground truth, expert adjudication, and training/test sets are not applicable or cannot be extracted from this document.

However, I can provide information based on the safety and performance testing described:

1. Table of Acceptance Criteria and Reported Device Performance

The document references compliance with specific ISO standards for dental materials. These standards define the acceptance criteria, and the device is reported to meet them.

Acceptance Criteria (Standard Reference)	Reported Device Performance
ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry	The device complies with the requirements described in ISO 7405:2008. (This implies it met the biocompatibility criteria defined in the standard.)
ISO 4049:2009 Dentistry - Polymer-based filling, restorative and luting materials	Performance testing has been performed in accordance with ISO 4049:2009 to demonstrate that the SA Flowable Composite is equivalent to or better than the predicate devices in terms of several material properties including film thickness, depth of cure, flexural strength, water sorption and solubility. (This implies it met or exceeded the criteria/performance of the predicate for these properties as defined or implied by the standard.)

Acceptance Criteria (Standard Reference)

Reported Device Performance

ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

The device complies with the requirements described in ISO 7405:2008. (This implies it met the biocompatibility criteria defined in the standard.)

ISO 4049:2009 Dentistry - Polymer-based filling, restorative and luting materials

Performance testing has been performed in accordance with ISO 4049:2009 to demonstrate that the SA Flowable Composite is equivalent to or better than the predicate devices in terms of several material properties including film thickness, depth of cure, flexural strength, water sorption and solubility. (This implies it met or exceeded the criteria/performance of the predicate for these properties as defined or implied by the standard.)

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

This information is not provided in the document. The document refers to general "performance testing" according to ISO standards, but details regarding sample sizes or data provenance for these tests are not included in this summary.

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

This information is not applicable as this is a dental material performance test, not a diagnostic device relying on expert interpretation of data. The "ground truth" here is established by standardized laboratory testing methods defined within the ISO standards.

4. Adjudication Method for the Test Set

This information is not applicable as there is no human interpretation or adjudication required for the physical and chemical property tests performed on a dental material.

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 is not applicable. This document describes a dental material, not an AI/ML device.

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

This is not applicable. This document describes a dental material, not an AI/ML device.

7. The Type of Ground Truth Used

The ground truth used for proving the device meets acceptance criteria is based on standardized laboratory measurements and tests of physical and chemical properties of the dental material, as defined by ISO 7405:2008 (biocompatibility) and ISO 4049:2009 (material properties like film thickness, depth of cure, flexural strength, water sorption, and solubility).

8. The Sample Size for the Training Set

This information is not applicable. This document describes a dental material, not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. This document describes a dental material, not an AI/ML device that requires a training set.

Summary

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K102603

510(k) Summary

000052

Trade Name:	SA Flowable Composite
Date Prepared:	August 31, 2010
Sponsor:	DMG USA, Inc.23 Frank Mossberg DriveAttleboro, MA 02703Owner/Operator No. 9005969
Device Generic Name:	Tooth Shade Resin Material
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II.
Regulation:	21 CFR 872.3690; Product Code EBF

Indications for Use:

SA Flowable Composite is a self-adhesive, light-curing, flowable composite. SA Flowable Composite applications include:

· Minor restorations of class I (without contact point)
· Underfillings of classes I and II
· Fissure sealing
· Repairs of composite restorations
· Modifications to temporaries and long-term temporaries
Blocking out and filling of undercuts

Device Description:

Predicate Device:

The SA Flowable Composite is substantially equivalent to the currently marketed Pentron Artiste SE Flowable Composite product cleared in K072545.

Safety and Performance:

SA Flowable Composite is a tooth shade resin material that complies with the requirements described in ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry and in ISO 4049:2009 Dentistry - Polymer-based filling, restorative and luting materials. Performance testing has been performed in accordance with ISO 4049:2009 to demonstrate that the SA Flowable Composite is equivalent to or better than the predicate devices in terms of several material properties including film thickness, depth of cure, flexural strength, water sorption and solubility.

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DMG USA, Inc. Abbreviated 510(k) Premarket Notification

Conclusion:

Based on the indications for use, technological characteristics, and comparison to the predicate device, the SA Flowable Composite has been shown to be substantially equivalent to its predicate devices, and safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

NOV 17 2010

Re: K102603

Trade/Device Name: SA Flowable Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF and EBC Dated: August 31, 2010 Received: September 10, 2010

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. 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.

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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); medical device reporting (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of . the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. 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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DMG USA, Inc. Abbreviated 510{k) Premarket Notification

August 31, 2010 SA Flowable Composite

Page

2102603 510(k) Number (if known):

Device Name: SA Flowable Composite

Product Indications for Use:

SA Flowable Composite is a self-etching, self-adhesive, light-curing, flowable composite.

SA Flowable Composite applications include:

Minor restorations of class I (without contact point) .
Underfillings of classes I and II .
Fissure sealing .
Repairs of composite restorations .
Modifications to temporaries and long-term temporaries ●

Blocking out and filling of undercuts ●
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)
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Suren Kumar

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

510(k) Number: K102603

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NOV 1 7 2010

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.