(38 days)
Rite-Dent Bonding System creates a bond between and all resin restorative materials. It consists of an Aola Lionany of the surface area for mechanical bonding. The The Librant clonod the onamer is interlock the etched area. After placement of Oatalyst and Dubo intinued and the monded enamel, a chemical bond will form between the composite and the tooth structure.
Enamel Bonding System
The provided text is a letter from the FDA regarding the 510(k) premarket notification for the "Enamel Bonding System" manufactured by Rite-Dent Manufacturing Corporation. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain information about acceptance criteria, device performance, study details (sample sizes, provenance, ground truth establishment, expert qualifications, adjudication methods), or multi-reader multi-case studies.
The letter is a regulatory approval document and focuses on the substantial equivalence determination for market entry, not on the technical performance data that would typically be reported in a clinical or performance study.
Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided text.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2002
Mr. Cesar E. Veliz VP Operations Rite-Dent Manufacturing Corporation 1056 East 33rd Street Hialeah, Florida 33013
Re: K020050
Trade/Device Name: Enamel Bonding System Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: December 26, 2001 Received: January 07, 2002
Dear Mr. Veliz:
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.
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
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Page 2 - Mr. Cesar E. Veliz
of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Tim & A. Ulatowski
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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INDICATIONS FOR USE
Rite-Dent Mfg. Corp. 1056 East 33rd Street Hialeah, FL 33013 Establishment # 1064592
510 (K) Number:
Unknown- K02-0050
Device Name: Indications for Use: Enamel Bonding System
elmo
Rite-Dent Bonding System creates a bond between and all resin restorative Rile-Dell Donding Oystem Croates materials. It consists of an Aola Lionany of the surface area for mechanical bonding. The The Librant clonod the onamer is interlock the etched area. After placement of Oatalyst and Dubo intinued and the monded enamel, a chemical bond will form between the composite and the tooth structure.
R.J. Betz DDS for Dr. Susan Renner
vision Sign-Off) vision of Dental, Infection Control, ிsion of Dental, Innection Controll.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.