The SternOmega Compomer LC is indicated for Class V restorations, cervical abrasions and erosions, Class III restorations, and for restorations of all cavity classes including Classes I and II in deciduous teeth.

The SternOmega Bonding Agent is indicated for all adhesive restorations with compomers and composites, including the SternOmega Composite LC and the SternOmega Compomer LC.

Device Description

The SternOmega Bonding Agent is a light-curing, one-component bonding agent for compomer and composite, which is applied to dentin and enamel. The bonding agent is self-conditioning, having the primer and bonding adhesive in one bottle.

The SternOmega Composite LC is a single-paste, light-curing, radiopaque universal hybrid composite dental filling material indicated for filling all classes of cavities. It is used in conjunction with the SternOmega Bonding Agent.

The SternOmega Compomer LC is a single-paste, light-curing, radiopaque dental filling material indicated for permanent filling of Class III and V cavities, and for temporary filing of Class I and II cavities. It is used in conjunction with the SternOmega Bonding Agent.

AI/ML Overview

The provided text is a 510(k) Summary for a dental composite system. It does not contain information about specific acceptance criteria, device performance metrics, or a study that proves the device meets those criteria.

Instead, it states that the submission is a "Special 510(k): Abbreviated 510(k)" and that Sterngold ImplaMed has provided information to demonstrate conformity with FDA's guidance document entitled Guidance for the Preparation of a Premarket Notification (510(k)) for Direct Filling Dental Composites, January 1996.

This means that the manufacturer is asserting substantial equivalence to predicate devices based on meeting the general requirements outlined in that FDA guidance document, rather than conducting a new, detailed performance study with explicit acceptance criteria for this specific device. The approval letter further confirms this by stating the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, I cannot fill out the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided document. The 510(k) summary focuses on demonstrating equivalence to existing products rather than presenting new performance data against novel acceptance criteria.

To answer your request thoroughly, a different type of document (e.g., a detailed clinical or performance study report) would be needed.

Summary

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K 98 X612

OCT 22 1998

510(k) Summary

Trade Name:	SternOmega Dental Composite System consisting of SternOmega BondingAgent, SternOmega Composite LC and SternOmega Compomer LC
Sponsor:	Sterngold ImplaMed23 Frank Mossberg DriveP.O. Box 2967Attleboro, MA 02703-0967Registration #2921595
Device Generic Name:	Dental composite system
Classification:	According to Section 513 of the Federal Food, Drug, and

Predicate Devices:

Product Name	510(k) #	Manufacturer
SternOmega Bonding Agent
Prime & Bond 2.1	K962348	Dentsply Int'l.
Optibond Solo Single Component	K940513	Kerr Mfg. Co.
Dentemp One Step	K964773	Bisco (Majestic Drug Co.)
Bond 1	K973388	Jeneric/Pentron Inc.
Single Bond	Unknown	3M
SternOmega Composite LC
XRV Herculite	K844662	Kerr Mfg. Co.
Prodigy AC	K963805	Sybron Dental Specialties
Renamel Hybrid	K921820	Cosmedent, Inc.
Charisma	K932013	Heraeus Kulzer
Tetric Ceram	K964285	Ivoclar North America
Tetric	K922569	Ivoclar North America
SternOmega Compomer LC
Compoglass	K951836	Ivoclar North America
Dyract	K950991	Dentsply Int'l.
Hytac Aplitip	K962442	ESPE

Product Description:

0 - 65,73

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Indications for Use:

The SternOmega Dental Composite System is indicated for dental filling of cavities.

The SternOmega Composite LC is indicated for filling of all classes of cavities.

The SternOmega Bonding Agent is indicated for all adhesive restorations with compomers and composites, including the SternOmega Composite LC and the SternOmega Compomer LC.

Safety and Performance:

This submission is a Special 510(k): 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), Sterngold ImplaMed has provided information to demonstrate conformity with FDA's guidance document entitled Guidance for the Preparation of a Premarket Notification (510(k)) for Direct Filling Dental Composites, January 1996.

Conclusion:

Based on the indications for use, technological characteristics, and comparison to predicate devices, the Stern Omega Dental Composite System has been shown to be safe and effective for its intended use.

C: 6: 1

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three lines forming its body and head. The bird is positioned diagonally within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 22 1998

Sterngold ImplaMed C/O Ms. Pamela Papineau Delphi Medical Device Consultant 50 Brewster Street Pawtucket, Rhode Island 02860

K982692 Re: SternOmega Bonding Agent, SternOmega Trade Name: Composite LC, SternOmega Compomer LC II Requlatory Class: Product Code: EBF July 27, 1998 Dated: August 3, 1998 Received:

Dear Ms. Papineau:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. বৈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Papineau

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041; or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510(k) Number (if known): _

Device Name: SternOmega Dental Composite System consisting of : SternOmega Bonding Agent, SternOmega Composite LC and SternOmega Compomer LC

Indications for Use:

The SternOmega Dental Composite System is indicated for dental filling of cavities.

The SternOmega Composite LC is indicated for filling of all classes of cavities:

The SternOmega Bonding Agent is indicated for all adhesive restorations with compomers and composites, including the SternOmega Composite LC and the SternOmega Compomer LC.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hevell Sheppes
(Division Sign-Off)

Division of Dental, Infection Control. and General Hospital Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-the -Counter Use

C30014

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.