(78 days)
Not Found
Not Found
No
The summary describes a dental material (resin composite) and does not mention any computational or analytical capabilities that would involve AI or ML.
No.
The device description indicates it is a material for core build-ups in dentistry, which is restorative and not primarily therapeutic in nature. While it is fluoride-releasing, which has preventive benefits, its core function as described is for fabrication/restoration, not treating a disease or disorder in a therapeutic sense.
No
The device is described as a "resin composite material" for "direct fabrication of core build-ups," which indicates it is a therapeutic or restorative material, not a tool for diagnosis.
No
The device description clearly states it is a "resin composite material," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is for "direct fabrication of core build-ups." This is a dental procedure performed directly on a patient's tooth.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
The description of CompCore™ AF does not involve the analysis of specimens taken from the body. It's a material used in a direct dental restoration procedure.
N/A
Intended Use / Indications for Use
CompCore™ AF is an automix, fluoride releasing, resin composite material designed for the direct fabrication of core build-ups.
Product codes
EBF
Device Description
CompCore™ AF is an automix, fluoride releasing, resin composite material designed for the direct fabrication of core build-ups.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The logo 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
SEP 2 7 2001
Premier Dental Products Company C/O Mr. Barry Hale Barry Hale C.Q.E. 7707 East 201 Terr Belton, Missouri 64012
Re: K012160
Trade/Device Name: CompCore™ AF Regulation Number: 872.2690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 11, 2001 Received: September 18, 2001
Dear Mr. Hale:
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 of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
Page 2 - Mr. Hale
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 (section 531-542 of the Act; 21); CFR 1000-1050.
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) 594-4613. 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 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,
K. Callatant
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
KO12160
Statement of Indications for Use
510(k) Number (If known) _ KO/ 乙/ 60
Device Name: CompCore™ AF
Indications for use: CompCore™ AF is an automix, fluoride releasing, resin composite material designed for the direct fabrication of core build-ups.
Please do not write below this line Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Per 21 CFR 801.109
or Over-the-Counter Use
Optional Format 1-2-96
Susan Runner
(Division Sign-Off) (Division Sign-on)
Division of Dental, Infection Control, and General Hospital Device E1 S010 F1 Click Number 510(k) Number ــ
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