(56 days)
This product is light-cured composite resin indicated to protect soft tissue during in-office bleaching.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to GC America, Incorporated, regarding the device "GC TiON GINGIVAL PROTECTOR." This document approves the device for market based on substantial equivalence to a predicate device, but it does not contain any information about acceptance criteria or a study proving that the device meets those criteria.
The letter focuses on the regulatory classification and general provisions for marketing the device. The "Indications for Use" section simply states the intended purpose of the device: "This product is light-cured composite resin indicated to protect soft tissue during in-office bleaching."
Therefore, I cannot provide the requested information based on the input text. There is no mention of:
- A table of acceptance criteria or reported device performance.
- Sample sizes, data provenance, or ground truth establishment for any test or training set.
- Expert involvement or adjudication methods.
- MRMC comparative effectiveness studies or standalone algorithm performance.
To fulfill your request, you would need to provide a document that describes the performance testing and associated results for the GC TiON GINGIVAL PROTECTOR.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center is an abstract design of an eagle with three stripes across its body. The eagle's head is facing left, and its wings are stylized.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 5 2005
Mr. Terry L. Joritz Director, Regulatory Affairs & Quality Control GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
Re: K043301
Trade/Device Name: GC TiON GINGIVAL PROTECTOR Regulation Number: 872.6300 Regulation Name: Rubber Dam and Accessories Regulatory Class: I Product Code: EIE Dated: November 29, 2004 Received: November 6, 2004
Dear Mr. Joritz:
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 practive, 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. Joritz
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DX 3 issualled of the vour device complies with other requirements mean that it 27 mas made a determind regulations administered by other Federal agencies. of the Act of ally I edelar statues and reguirements, including, but not limited to: registration 1 ou must colliply with an the Fice o req 21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), labolity systems (QS) regulation (21 CFR Part 820); and if requirements us set form in the quadisation 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) This letter will anow you to begal mading of substantial equivalence of your device to a premarket notification. The PDF 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), If you desire specific advice for your at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Parl 807.97). You may obtain other general information on your responsibilities under the Act from the may other of Small Manufacturers, International and Consumer Assistance at its toll-free Drimber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Chiu Liu, Ph.D.
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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Indications for Use
510(k) Number (if known): _
Ko 43301
GC TiON GINGIVAL PROTECTOR Device Name:
Indications for Use:
This product is light-cured composite resin indicated to protect soft tissue during in-office bleaching.
Prescription Use (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Smer Ramos
(Division Sign-Off) Division of Ane thesiology, General Hospital, Infection Control, Dental Devices
210(k) Number:
Page 1 of 1
§ 872.6300 Rubber dam and accessories.
(a)
Identification. A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.(b)
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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.