(76 days)
TempBond Clear - 2 is a dual-cured, temporary resin-based cement designed to be used in conjunction with temporary restorations such as crowns, bridges, inlays and onlays.
The device is a dual cured, self-cured and visible light-cured, resin-based cement designed to be used in conjunction with temporary crowns, bridges, inlays and onlays. The highly translucent nature of TempBond Clear - 2 provides a pleasing, tooth-like appearance even when margins are exposed.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary for a dental cement called "TempBond Clear - 2", which includes general device information, its intended use, and substantial equivalence claim to another legally marketed device. It also includes an FDA letter confirming the device's substantial equivalence and allowing it to be marketed.
Therefore, I cannot provide the requested table or answer the questions regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications, as this information is not present in the given text.
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Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: July 1998
Device Name:
- Trade Name TempBond Clear 2 .
- . Common Name - Temporary Dental Cement
- Classification Name Dental Cement other than zinc oxide-eugenol, per 21 CFR & . 872.3275
Devices for Which Substantial Equivalence is Claimed:
- Kerr Corporation, TempBond Clear .
Device Description:
The device is a dual cured, self-cured and visible light-cured, resin-based cement designed to be used in conjunction with temporary crowns, bridges, inlays and onlays. The highly translucent nature of TempBond Clear - 2 provides a pleasing, tooth-like appearance even when margins are exposed.
Intended Use of the Device:
The intended use of TempBond Clear - 2 is for temporary cementation of temporary restorations such as crowns, bridges, inlays and onlays.
Substantial Equivalence:
TempBond Clear - 2 is substantially equivalent to several other legally marketed devices in the United States. The temporary dental cement marketed by Kerr Corporation functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 8 1998
Ms. Colleen Boswell Senior Regulatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Oranqe, California 92867
Re : K982590 Trade Name: TempBond Clear - 2 Regulatory Class: II Product Code: EMA Dated: July 24, 1998 Received: July 24, 1998
Dear Ms. Boswell:
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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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. 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 regulations.
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Page 2 - Ms. Boswell
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 connect 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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Section 1 - Indications for Use
510(k) Number:
TempBond Clear - 2 Device Name:
Indications for Use:
TempBond Clear - 2 is a dual-cured, temporary resin-based cement designed to be used in conjunction with temporary restorations such as crowns, bridges, inlays and onlays.
(Division Sign-Off)
(Division Sign-Off)
[Prescription Device
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K982590
§ 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.