(112 days)
- · For direct bonding of composite resin to dentin and enamel.
- · For direct bonding of composite resin to dentin and enamel in the co-cured technique.
- · For direct bonding of composite resin to GI self cure or GI light cure base base base on and enamel in the "sandwich" technique.
- · For · sealing to hypersensitive cervical areas and root surfaces of teeth.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the Riva Bond LC device. The document is a 510(k) premarket notification letter from the FDA, confirming the substantial equivalence of the Riva Bond LC to a legally marketed predicate device. It defines the indications for use but does not include details about performance studies or acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.
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Image /page/0/Picture/9 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 entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration
9200 Corporate Boulevard Rockville MD 20850
NOV - 9 2008
Mr. Ray Cahill Technical Director Southern Dental Industries. Incorporated 729 North Route 83, Suite 315 Bensenville, Illinois 60106
Re: K062064 Trade/Device Name: Riva Bond LC Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: October 30, 2006 Received: November 6, 2006
Dear Mr. Cahill:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Cahill
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements. Incall that I DA mas made a wees and regulations administered by other Federal agencies. of the Act of ally I ederal station and sequirements, including, but not limited to: registration 1 ou intist contiply with and 107); labeling (21 CFR Part 801); good manufacturing practice and ilsting (21 CF R Parvov), arrality systems (QS) regulation (21 CFR Part 820); and if requirements us bet form arrative tradiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), 11 you don't the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Suyite Y. Michaud.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name:
Indications For Use:
Kole 204
Riva Bond LC
- · For direct bonding of composite resin to dentin and enamel.
- · For direct bonding of composite resin to dentin and enamel in the co-cured technique.
- · For direct bonding of composite resin to GI self cure or GI light cure base base base on and enamel in the "sandwich" technique.
- · For · sealing to hypersensitive cervical areas and root surfaces of teeth.
(Please Do Not Write Below This Line - Continue on Another Page if Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
|---|---|
| 510(k) Number: | K062061 |
| Prescription Use: | / | OR | Over-The-Counter Use: | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
§ 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.