(161 days)
No
The device description focuses on the material composition and curing process, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No.
The device is a restorative dental material used to fill cavities and build up tooth structure, rather than to treat or cure a disease or condition.
No
Explanation: The device is described as a "permanent restorative material" used for filling cavities and other dental restoration purposes. Its function is to harden and form a restoration, not to diagnose a condition.
No
The device is a dental restorative material, which is a physical substance used in dentistry, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a "permanent restorative material" for dental cavities, bases, laminates, root canal lesions, and core build-ups. This is a therapeutic and structural function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a light-curing dental restorative material that hardens and forms a polymer. This is consistent with a material used to fill or rebuild tooth structure.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, tissue, etc.) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to restore and repair tooth structure.
N/A
Intended Use / Indications for Use
Used as a permanent restorative material in all cavity classes for both permanent and deciduous teeth; as a base material underneath amalgams, ceramics, cast metal restorations, and composites; as a laminate or open sandwich technique; for root canes lesions; and for core build-up
Product codes
EBF
Device Description
DYRACT® AP RESTORATIVE is a one-component, visible light curing, dental restorative material, delivered in COMPULES®, which hardens upon polymentation. The composition is polymenzed by brief exposure to visible light from a dental curing light. When polymenzation occurs, the monomers cross-link to form polymer-containing carboxyl groups which are capable of further reaction with cations eluted from the glass-reinforcing filler to form a salt, as in DYRACT® II Restorative (K950991). The modifications to the DYRACT II Restorative serve to enhance the strength and wear resistance of DYRACT AP RESTORATIVE.
The physical properties of DYRACT AP RESTORATIVE and the predicate device are similar.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
DYRACT AP RESTORATIVE (cured material) was tested by the Ames Mutagenicity Test and Guinea Pig Sensitization Test. The cured material is non-mutagenic and a non-sensitizer.
Key Metrics
Not Found
Predicate Device(s)
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
510(k) SUMMARY
Image /page/0/Picture/2 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and appear to be in black. The font is stylized, with some letters having sharp angles and cutouts. The overall impression is of a strong, established brand name.
NAME & ADDRESS:
DENTSPLY International
570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fox 171718542343
P. J. Lehn Telefax (717) 849-4343
| CONTACT: | P. Jeffery Lehn | |
|---|---|---|
| DATE PREPARED: | August 27, 1997 | |
| TRADE OR PROPRIETARY NAME: | DYRACT® AP RESTORATIVE | |
| CLASSIFICATION NAME: | Tooth resin shade material | 872.3690 |
| PREDICATE DEVICE: | DYRACT® II Restorative | K950991 |
DYRACT® AP RESTORATIVE is a one-component, visible light DEVICE DESCRIPTION: curing, dental restorative material, delivered in COMPULES®, which hardens upon polymentation. The composition is polymenzed by brief exposure to visible light from a dental curing light. When polymenzation occurs, the monomers cross-link to form polymer-containing carboxyl groups which are capable of further reaction with cations eluted from the glass-reinforcing filler to form a salt, as in DYRACT® II Restorative (K950991). The modifications to the DYRACT II Restorative serve to enhance the strength and wear resistance of DYRACT AP RESTORATIVE.
The physical properties of DYRACT AP RESTORATIVE and the predicate device are similar.
INTENDED USE: DYRACT AP RESTORATIVE is used as a permanent restorative material in all cavity classes for both permanent and deciduous teeth: as a base material underneath amalgams, ceramics, cast metal restorations, and composites; as a laminate or open sandwich technique; for root caries lesions: and for core build-up.
TECHNOLOGICAL CHARACTERISTICS: All components in DYRACT AP RESTORATIVE have been used in legally marketed devices or found to be safe for dental use.
DYRACT AP RESTORATIVE (cured material) was tested by the Ames Mutagenicity Test and Guinea Pig Sensitization Test. The cured material is non-mutagenic and a non-sensitizer.
We believe that the prior use of the components of DYRACT AP RESTORATIVE in legally marketed predicate devices, the results of the toxicity and sensitization testing, and the performance data support the safety and effectiveness of DYRACT AP RESTORATIVE for the indicated uses.
Image /page/0/Picture/16 description: The image shows a sequence of numbers, specifically "000014". The numbers are printed in a bold, sans-serif font, and they appear to be part of a larger document or label. The digits are evenly spaced and aligned horizontally.
1
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three faces in profile, one behind the other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 5 1998
Mr. P. Jeffrey Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue York, Pennsylvania 17405
K973235 Re : DYRACT® AP RESTORATIVE Trade Name: Regulatory Class: II Product Code: EBF January 28, 1998 Dated: January 30, 1998 Received:
Dear Mr. Lehn:
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, 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 (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. A substantially equivalent determination assumes .compliance .with ........ the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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
2
Page 2 - Mr. Lehn
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 requlation (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,
Timothy A. Ulatowski
Timo Directo Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 801.109)
510(K) Number:
Device Name:
DYRACT® AP RESTORATIVE
Indications for Use:
Used as a permanent restorative material in all cavity classes for both permanent and deciduous teeth; as a base material underneath amalgams, ceramics, cast metal restorations, and composites; as a laminate or open sandwich technique; for root canes lesions; and for core build-up
Concurence of CDRH. Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices K973233
Prescription Use
OR
Over-The-Counter Use
000007