(35 days)
SternOmega Temporary Cement Automix NE is indicated for use as a temporary cement for attaching all types of temporaries, e.g. temporary crowns, bridges, and inlays.
The SternOmega Temporary Cement Automix NE is an auto-mixing, non-eugenol cement indicated for the temporary bonding of crowns, bridges and inlays.
The Sterngold ImplaMed Abbreviated 510(k) Premarket Notification for the SternOmega Temporary Cement Automix NE does not contain information regarding acceptance criteria or a study proving the device meets said criteria.
The document explicitly states:
"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 Temporary Cement Automix NE are equivalent to those of the predicate device."
Therefore, I cannot provide a response to your numbered points as the requested information is absent from the provided text. The submission relies solely on demonstrating substantial equivalence to a predicate device (TempoCem NE) based on design and material characteristics, rather than presenting new performance or safety study data.
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Sterngold ImplaMed Abbreviated 510(k) Premarket Notification
Image /page/0/Picture/1 description: The image shows the date December 2, 1998, and the text "SternOmega Temporary Cement Automix NE". Above the text, there is a sequence of numbers that appears to be "<984340". The text and numbers are in black and white, and the image appears to be a scan of a document.
JAN 8 1999
510(k) Summary
Trade Name:
Stern Omega Dental Temporary Cement Automix NE
Sponsor:
Sterngold ImplaMed 23 Frank Mossberg Drive P.O. Box 2967 Attleboro, MA 02703-0967 Registration #2921595
Device Generic Name: Dental bonding agent
Classification: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II.
Predicate Device: The proposed SternOmega Temporary Cement Automix NE is substantially equivalent to the TempoCem NE temporary dental cement marketed by Foremost Dental Manufacturing, Inc. which was cleared for marketing by FDA in K970774.
Product Description:
The SternOmega Temporary Cement Automix NE is an auto-mixing, non-eugenol cement indicated for the temporary bonding of crowns, bridges and inlays.
Indications for Use:
SternOmega Temporary Cement Automix NE is indicated for use as a temporary cement for attaching all types of temporaries, e.g. temporary crowns, bridges, and inlays.
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 Temporary Cement Automix NE are equivalent to those of the predicate device.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to the predicate device, the SternOmega Temporary Cement Automix NE 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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1999 JAN
Mr. Gordon Nelson Director Sterngold ImplaMed 23 Frank Mossberg Drive P.O. Box 2967 02703-0967 Attleboro, Massachusetts
Re: K984340 SternOmega Temporary Cement Automix NE Model Trade Name: 220282/220281 Requlatory Class: II Product Code: EMA Dated: December 2, 1998 Received: December 4, 1998
Dear Mr. Nelson:
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, Druq, 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 Requlations, Title 21, Parts 800 to 895. A 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 requlations.
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Page 2 - Mr. Nelson
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 leqally 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 labelinq 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 requlation 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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Sterngold ImplaMed Abbreviated 510(k) Premarket Notification
Page 1 of 1
510(k) Number (if known): K984340
Device Name: SternOmega Temporary Cement Automix NE
Indications for Use:
SternOmega Temporary Cement Automix NE is indicated for use as a temporary cement for attaching all types of temporaries, e.g. temporary crowns, bridges, and inlays.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-the -Counter Use (Per 21 CFR 801.109) Division of Dental, Infection Control, and General Hospital 510(k) Number
§ 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.