(36 days)
Not Found
No
The summary describes a dental restorative material and its intended use, focusing on its physical properties and comparison to a predicate device. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML.
No.
The device is a restorative material used for filling cavities in teeth, which is not considered a therapeutic device. It does not treat or cure a disease but rather replaces damaged tooth structure.
No
The device, R-30 AESTHETIC RESTORATIVE, is described as a "direct restorative material" and "restorative material" used for "cavity classes I, II, III, IV, V and VI in anterior and posterior teeth." Its purpose is to restore damaged teeth, not to diagnose a condition.
No
The device description clearly states it is a "visible light activated, radiopaque restorative material" packaged in "syringes or compules," indicating it is a physical material, not software.
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 "direct restorative material" for filling cavities and creating veneers and inlays/onlays in teeth. This is a therapeutic and restorative function performed directly on the patient's body.
- Device Description: The description confirms it's a "visible light activated, radiopaque restorative material" used with a dental adhesive. This further reinforces its use in direct dental procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used to perform tests on samples taken from the body to aid in diagnosis or monitoring. This device is a material used to repair and restore the structure of teeth.
N/A
Intended Use / Indications for Use
R-30 AESTHETIC RESTORATIVE is to be used with Prime & Bond® NT™ Dental Adhesive System for cavity classes I, II, III, IV, V and VI in anterior and posterior teeth as a direct restorative material, anterior direct veneering material, and may be used for the fabrication of indirect inlays and onlays.
Product codes
EBF
Device Description
R-30 AESTHETIC RESTORATIVE is a visible light activated, radiopaque restorative material for anterior and posterior restorations of primary and permanent teeth. It is to be used with Prime & Bond® NT™ Dental Adhesive System. The material is a one-component, VLC composite restorative, packaged in syringes or compules.
The physical properties of R-30 AESTHETIC RESTORATIVE meet ISO Standard 4049.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior teeth
Indicated Patient Age Range
primary and permanent teeth
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)
The results of Ames testing on the main components were negative.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/1 description: The image shows a logo with a bold, sans-serif typeface. The logo consists of a solid black circle on the left, followed by the letters 'DENT' in a bold font. There is a horizontal line above the letters 'DENT', which adds a visual element to the logo. The overall design is simple, modern, and easily recognizable.
NAME & ADDRESS:
DENTSPLY International
570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fax (717) 854-2343
JAN 1 3 1999
P. J. Lehn Telefax (717) 849-4343
CONTACT: P. Jeffery Lehn
December 3, 1998 DATE PREPARED:
TRADE OR PROPRIETARY NAME: R-30 AESTHETIC RESTORATIVE
COMMON OR USUAL NAME: Dental restorative material
CLASSIFICATION NAME: Tooth resin shade material
PREDICATE DEVICE: SureFil™ High Density Posterior Restorative K973221
R-30 AESTHETIC RESTORATIVE is a visible light activated, DEVICE DESCRIPTION: radiopaque restorative material for anterior and posterior restorations of primary and permanent teeth. It is to be used with Prime & Bond® NT™ Dental Adhesive System. The material is a one-component, VLC composite restorative, packaged in syringes or compules.
The physical properties of R-30 AESTHETIC RESTORATIVE meet ISO Standard 4049.
INTENDED USE: R-30 AESTHETIC RESTORATIVE is to be used with Prime & Bond® NT™ Dental Adhesive System for cavity classes I, II, III, IV, V and VI in anterior and posterior teeth as a direct restorative material, anterior direct veneering material, and may be used for the fabrication of indirect inlavs and onlays.
TECHNOLOGICAL CHARACTERISTICS: The new R-30 AESTHETIC RESTORATIVE is substantially equivalent to the predicate device, K973221 (SureFil™ High Density Posterior Restorative).
We believe that the prior use of the R-30 AESTHETIC RESTORATIVE components in the predicate device supports our decision that additional biocompatibility studies with the final formulation are not necessary.
The results of Ames testing on the main components were negative.
We believe that the prior use of the components in the R-30 AESTHETIC RESTORATIVE in the predicate device, the performance data provided, and the results of previous biocompatibility testing support the safety and effectiveness of R-30 AESTHETIC RESTORATIVE for the intended uses.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, one behind the other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 1999
Mr. P. Jeffrey Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
K984387 Re : R-30 Aesthetic Restorative Trade Name: Requlatory Class: II Product Code: EBF Dated: December 3, 1998 December 8, 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, Druq, 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 aqainst 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 Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Lehn
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) 594-4692. 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
Timothy A. Ulatowski Director 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
510(K) Number:
Device Name:
R-30 AESTHETIC RESTORATIVE
R-30 AESTHETIC RESTORATIVE is to be used with Prime & Bond® NT™ Dental Adhesive System for cavity classes I, II, III, IV, V and VI in anterior and posterior teeth as a direct restorative material, anterior direct veneering material, and may be used for the fabrication of indirect inlays and onlays.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Sisen Russe
ivision of Dental, Infection Control, and General Hospital Devices
510(k) Number
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