(53 days)
SternOmega Compomer Cement Automix is indicated for use in permanent luting of crowns, bridges, inlays and onlays and for luting ceramic crowns, inlays and veneers.
The SternOmega Dental Compomer Cement is an auto-mixing, chemical cure, radiopaque cement indicated for the permanent luting of crowns, bridges, inlays and onlays. The cement contains fluoride which is released over time to provide the benefits associated with a fluoride-releasing material.
The provided document is a 510(k) Premarket Notification for the SternOmega Dental Compomer Cement Automix. It explicitly states that "Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification."
Therefore, it is not possible to describe acceptance criteria or a study proving the device meets them from this document. The manufacturer did not submit performance data.
The document indicates that the device's equivalence was based on a comparison to several predicate devices. This means that the FDA determined the new device was substantially equivalent to existing, legally marketed devices based on its intended use, technological characteristics, and design, without requiring a specific performance study from the applicant.
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Sterngold ImplaMed Special 510(k) Premarket Notification: Abbreviated 510(k)
OCT - 9 1998
| Trade Name: | SternOmega Dental Compomer Cement Automix |
|---|---|
| Sponsor: | Sterngold ImplaMed23 Frank Mossberg DriveP.O. Box 2967Attleboro, MA 02703-0967Registration #2921595 |
| Device Generic Name: | Dental bonding agent |
| Classification: | According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II |
The proposed SternOmega Compomer Cement is substantially equivalent to a Predicate Devices: number of currently marketed dental cements and bonding agents including the following:
| Product/510(k) # | Manufacturer |
|---|---|
| Optibond/K940513 | Kerr |
| Panavia 21/K933030 | Kuraray/J. Morita |
| C&B Luting Composite/K940030 | Bisco |
| Flexi-Flow/K922249 | EDS |
| C&B Metabond/K960464 | Parkell |
| Duolink/K943596 | Bisco |
| Variolink/931309 | Vivadent |
| Advance/K940914 | Dentsply |
| Dyract Cem/Unknown | Dentsply |
| Fuji Duet (Fuji Plus)/K946100 | GC |
| Resinomer/K924151 | Bisco |
| Cement-It/Unknown | Jeneric/Pentron |
| ABC Dual Adhesive Bridge Cement/Unknown | Vivadent |
Product Description:
The SternOmega Dental Compomer Cement is an auto-mixing, chemical cure, radiopaque cement indicated for the permanent luting of crowns, bridges, inlays and onlays. The cement contains fluoride which is released over time to provide the benefits associated with a fluoride-releasing material.
Indications for Use:
The SternOmega Compomer Cement is indicated for permanent luting of crowns, bridges, inlays and onlays and for luting ceramic crowns, inlays and veneers.
Safety and Performance:
Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the Compomer Cement are equivalent to those of the predicate devices.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the SternOmega Dental Compomer Cement has been shown to be safe and effective for its intended use.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUM" written along the left side and "SERVICES • USA" written along the top. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sterngold ImplaMed C/O Ms. Pamela Papineau Delphi Medical Device Consultant 50 Brewster Street Pawtucket, Rhode Island 02860
Re : K982895 --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Trade Name: Sternomega Compomer Cement Regulatory Class: II Product Code: EMA Dated: August 14, 1998 Received: August 17, 1998
Dear Ms. Papineau:
OCT - 9 1998
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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬੈ 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 regulation (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 bo
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): K982895
Device Name: SternOmega Compomer Cement Automix
Indications for Use:
SternOmega Compomer Cement Automix is indicated for use in permanent luting of crowns, bridges, inlays and onlays and for luting ceramic crowns, inlays and veneers.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runsoe
(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use v (Per 21 CFR 801.109)
OR
Over-the -Counter Use
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.