(77 days)
Not Found
Not Found
No
The summary describes a dental restorative material and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device is described as a "High density restorative for cavity preparation in posterior teeth" and "May be used as an indirect restorative for inlays and onlays," which points to it being a dental material used for restoration rather than a therapeutic device that treats or prevents disease.
No
The device is described as a "High density restorative for cavity preparation." This indicates it is used for treatment (restoration) rather than diagnosis.
No
The device is described as a "high density restorative for cavity preparation," which is a physical material used in dentistry, 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 described as a "High density restorative for cavity preparation in posterior teeth" and "indirect restorative for inlays and onlays." This describes a material used directly in the mouth for dental restoration.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The description clearly indicates a device used in vivo (within the living body) for structural restoration, not a test performed on a sample in vitro (outside the living body).
N/A
Intended Use / Indications for Use
High density restorative for cavity used as an indirect be May May be ased as a and for the restorative interest and onlays.
Product codes
EBF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2001
Southern Dental Industries, Limited C/O Ms. Samantha J. Cheetham Official Correspondent Southern Dental Industries, Incorporated 729 N. Route 83, Suite 315 Bensenville, Illinois 60106
Re: K012529
Trade/Device Name: ROK Regulation Number: 872.3690 Regulation Name: Dental Composite-Poterior Restorative Regulatory Class: II Product Code: EBF Dated: July 30, 2001 Received: August 6, 2001
Dear Ms. Cheetham:
We have reviewed your Section 510(k) premarket notification of intent to market the device t We have reviewed your Scellon 310(x) profishing is substantially equivalent (for the referenced above and have declinities and to legally marketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed of the Medical De indications for use stated in the enclosales to the enactment date of the Medical Device interstate commerce phor to way 20, 1270, all ssified in accordance with the provisions of
Amendments, or to devices that have been recurres approval of a premarket Amendments, or to devices that nave been for require approval of a premaxed
the Federal Food, Drug, and Cosmetic Act (Act) that do subject to the general the Federal Food, Drug, and Cosmene Act (Pree) and elevice, subject to the general
approval application (PMA). You may, therefore, market the device, subject to the general approval application (FMA). You may, and controls provisions of the Act include controls provisions of the Act. The gentine of devices, good manufacturing practice,
requirements for annual registration, listing of devices to a requirements for unitude regainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III) If your device is classified (sec above) in o controls. Existing major regulations affecting (PMA), it may be subject to such additional controllar controllations, Title 21, Farts 800 to 898. In the Federal your device can be found in the Code of Pederal regarities of the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualled of a bacouanial one complies with other requirements
1
Page 2 - Ms. Cheetham
of the Act or any Federal statutes and regulations administered by other Federal agencies.
The status and the section and security and including, but not limited to: registra of the Act or any Federal statutes and reginations annuding, but not limited to: registration
You must comply with all the Act a requirements, including bractice You must comply with all the Act s' requirences increating on anaufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807); labeling (21 CFR Parts) 9 (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality systems (QD) regulation (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 This letter will allow you to begin marketing you device leguivalence of your device to
510(k) premarket notification. The FDA finding of stostian for your device and thus, 510(k) premarket notification. The FDA Indians of deboation for your device and thus,
a legally marketed predicate device results in a classification for your device and thus a legally manowice to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801
000 (2008) (2008) (2008) (2006 (2006) (2000 (2000) please contact the If you desire specific advice io your device on vitro diagnostic devices), please contact the and additionally 21 CFR Part 809.10 Ior in Villo Glagliostion on the promotion and
Office of Compliance at (301) 594-4613 . Additionally, for questions on the promotion and Office of Compliance at (301) 394-4013 : "Additions") Compliance at (301) 594-4639.
advertising of your device, please contact the Office has reference premarket advertising of your device, prease contact and or reference to preference to premarket. Also, please note the regulation entined, "miseral information on your responsibilities under
notification" (21CFR Part 807.97). Other general informational and notification" (21CFR Part 807.97). Outlet Return and Manufacturers, International and
the Act may be obtained from the Division of Small Manufacturers, International and the Act may be obtained from the Division of 800 638-2041 or (301) 443-6597 or at its
Consumer Assistance at its toll-free number (800) 638-2041 de may Consumer Assistance at its toil-froo hamost (00)
Internet address http://www.fida.gov/cdrch/dsma/dsmamain.html.
Sincerely yours,
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
Page 1 of 1
510(k) Number (if known):
ROK
Device Name:
Indications For Use:
High density restorative for cavity High 'Gensity' Fourther teeth.
used as an indirect be May May be ased as a and for the restorative interest and onlays.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K012509 |
| Prescription Use: | OR | Over-The-Counter Use: | ||
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |