(56 days)
Not Found
Not Found
No
The summary describes a light-cured composite resin for soft tissue protection, with no mention of AI, ML, image processing, or any computational analysis.
No.
The device is a composite resin used to protect soft tissue, not to treat a disease or condition.
No
Explanation: The device is a light-cured composite resin indicated to protect soft tissue during in-office bleaching. Its intended use is protective/therapeutic, not for diagnosing a condition or disease.
No
The device description is not found, but the intended use clearly describes a physical material (light-cured composite resin) used for protection, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "protect soft tissue during in-office bleaching." This describes a physical barrier or protective material applied to the body, not a test performed on a sample taken from the body to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or screening
The device appears to be a dental material used in a clinical procedure.
N/A
Intended Use / Indications for Use
This product is light-cured composite resin indicated to protect soft tissue during in-office bleaching.
Product codes
EIE
Device Description
light-cured composite resin
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (gingival)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
in-office
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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:
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