(92 days)
ENCORE BOND is a self-cure bonding agent for dentin and enamel and the considering is and applied in a thin coating to ENCORE BOND is a self-cure bonding agains a thin coating to tooth surfaces. It is mixed and apprica in a case of the composite resins to tooth structure.
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The provided text is a 510(k) premarket notification letter from the FDA to Centrix Incorporated regarding their device, Encore Bond. It states that the device has been reviewed and determined to be substantially equivalent to devices marketed prior to May 28, 1976, and therefore can be marketed.
However, this document DOES NOT contain information about acceptance criteria, device performance results, study design details (sample sizes, data provenance, expert qualifications, ground truth establishment, adjudication methods, MRMC studies, or standalone performance), or training set information.
The document is purely a regulatory approval letter. To answer the questions posed, I would need access to the actual 510(k) submission summary or detailed study reports for Encore Bond, which are not included in the provided text.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads facing right, representing service to the people. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Discko ·Executive Vice President Centrix Incorporated 770 River Road Shelton, Connecticut 06484-5458
JUN 27 1997
K971121 Re : Encore Bond Trade Name: Regulatory Class: II Product Code: KLE Dated: April 24, 1997 Received: April 29, 1997
Dear Mr. Discko:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸਾ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
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Page 2 - Mr. Discko
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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) 594-4618. 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" (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
U. Uhlstrist
A. Ulatowski Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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of Page_
| 510(k) Number (if known): | K971121 |
|---|---|
| Device Name: | ENCORE BOND |
Indications For Use: ... . . . . . .........
ENCORE BOND is a self-cure bonding agent for dentin and enamel
and the considering is and applied in a thin coating to ENCORE BOND is a self-cure bonding agains a thin coating to tooth surfaces. It is mixed and apprica in a case of the composite resins to tooth structure.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suan Rumper
(Division Sign-Off) (Division of Dental, Infection Control, Divisioneral Hospital Da 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use No
(Optional Format 1-2-96)
§ 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.