(98 days)
FUTURA GLASS IONOMER SILVER REINFORCED RESTORATIVE is to be used as a base, lining and filling material for restoring function to teeth which have lost portions to caries:
- Class I and II cavities in deciduous teeth.
- Repair of amalgam restored teeth (fractured restoration or tooth).
- Class I and II cavities in selected permanent teeth.
- Lining under amalgam or posterior composite restorations.
- Cavities where radiopacity is a prime requirement.
- Core build up material under crowns.
- On root surface for locating overdentures.
- Long term temporary replacement of cusps
- Repairs to crown margins.
Not Found
I'm sorry, but the provided text does not contain the information requested about acceptance criteria and a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for a dental restorative material (Futura Glass Ionomer Silver Reinforced Restorative), indicating that the device is substantially equivalent to a legally marketed predicate device.
The information you've requested typically involves performance data, study designs, sample sizes, and expert qualifications, which are not detailed in this regulatory clearance letter. This letter primarily confirms that the device can be legally marketed based on its equivalence to existing products, rather than providing a comprehensive report on its clinical performance and the studies used to establish specific performance criteria.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a human figure or a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 1999
AB Ardent Clyde E. Ingersoll C/O: Ardent Product Development 54 Riverview Avenue Tonawanda, NY 14150
Re : K991974 Futura Glass Ionomer Silver Reinforced Trade Name: Restorative Requlatory Class: II Product Code: EMA Dated: Auqust 28, 1999 September 2, 1999 Received:
Dear Mr. Ingersoll:
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) requlation (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 requlation may result in requlatory 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 obliqation you might have under sections 531 through 542 of
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Page 2 -Mr. Ingersoll
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acborized 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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4690. 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 the regaracion chercica) : IBBranding 77 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.fdac.gov/cdrh/dsmamain.html".
Sincerely Yours,
Timothy A. Ulatowski
liv A. 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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AB ARDENT
Generatorgatan 8 S-195 60 Marsta Sweden +046 8 591 210 20 Phone +046 8 591 161 83 FAX
510 (K)
FUTURA GLASS IONOMER SILVER REINFORCED RESTORATIVE
ATTACHMENT #4
INDICATIONS FOR USE
510(k) Number: number not yet assigned
Device Name: FUTURA GLASS IONOMER SILVER REINFORCED RESTORATIVE
FUTURA GLASS IONOMER SILVER REINFORCED RESTORATIVE is to be used as a base, lining and filling material for restoring function to teeth which have lost portions to caries:
- Class I and II cavities in deciduous teeth. 1.
-
- Repair of amalgam restored teeth (fractured restoration or tooth).
- Class I and II cavities in selected permanent teeth. 3.
-
- Lining under amalgam or posterior composite restorations.
-
- Cavities where radiopacity is a prime requirement.
-
- Core build up material under crowns.
-
- On root surface for locating overdentures.
-
- Long term temporary replacement of cusps
- ல் Repairs to crown margins.
For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.
Prescription use
(Division Sign-Off) famila Scott for Sucan Runner Division of Dental, Infection Control, and General Hospital Devices તુવાપા 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.