(166 days)
Not Found
No
The 510(k) summary describes a dental restorative material and adhesive system, focusing on physical properties and intended use for filling cavities. There is no mention of AI, ML, image processing, or any computational analysis of data.
No.
This device is a dental restorative material used to fill cavities in teeth, which is a structural and restorative function, not a therapeutic one that treats or cures a disease.
No
Explanation: The device is described as a "restorative material" and is indicated for "cavity Classes I, II, III, IV, V, and VI in anterior and posterior teeth." Its purpose is to restore teeth, not to diagnose conditions.
No
The device description clearly states it is a "visible light activated, radiopaque restorative material" and is "packaged in unit dose or syringes," indicating it is a physical material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "restorative material" for "cavity Classes I, II, III, IV, V, and VI in anterior and posterior teeth." This describes a material used directly on the patient's teeth for repair and restoration.
- Device Description: The description reinforces this, calling it a "visible light activated, radiopaque restorative material for anterior and posterior restorations."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples. This device is used inside the body to restore dental structure.
N/A
Intended Use / Indications for Use
COMPOSITE 168 RESTORATIVE SYSTEM is to be used with Prime & Bond™ 2.1 Universal Light Cured Dental Adhesive System:
• Indicated for cavity Classes I, II, III, IV, V, and VI in anterior and posterior teeth.
•May be used as a direct restorative material
•May be used for fabrication of inlays and onlays
Product codes
EBF
Device Description
COMPOSITE 168 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 2.1 Universal Light Cured Dental Adhesive System. This one-component. VLC composite restorative is packaged in unit dose or svringes.
The physical properties of COMPOSITE 168 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
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
The non-clinical tests used for this submission are similar to those specified in ISO 4049 and American Dental Association Specification #27; both are for dental resin based filling materials. Diametral tensile testing (DTS) is an accepted method to characterize the tensile strength of brittle materials and the flexural modulus test addresses the strength in three point loading. DTS values are 41.3 and 39.0 MPa for NTL-FLOW and AELITEFLO respectively. Cytotoxicity of NTL-FLOW was performed by a commercial testing laboratory (NAMSA) and the product was found to be non-toxic.
Key Metrics
DTS values are 41.3 and 39.0 MPa for NTL-FLOW and AELITEFLO respectively.
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
FEB - 9 1998
510(k) SUMMARY
)
ﻣﺴﻴﺔ
NAME & ADDRESS:
DENTSPLY International
570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 ax 1777 854-2343
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
August 20 . 1997 DATE PREPARED:
COMPOSITE 168 RESTORATIVE SYSTEM TRADE OR PROPRIETARY NAME:
Dental restorative material COMMON OR USUAL NAME:
CLASSIFICATION NAME: Tooth resin shade material
K863092 Dental Composite Restorative PREDICATE DEVICE: SDI Composites K941899
DEVICE DESCRIPTION: COMPOSITE 168 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 2.1 Universal Light Cured Dental Adhesive System. This one-component. VLC composite restorative is packaged in unit dose or svringes.
The physical properties of COMPOSITE 168 RESTORATIVE meet ISO Standard 4049.
INTENDED USE: COMPOSITE 168 RESTORATIVE SYSTEM is substantially equivalent in intended use to the predicate device, K941899 (SDI Composites). It is to be used with Prime & Bond™ 2.1 Universal Light Cured Dental Adhesive System and it:
a. Is indicated for cavity Classes I, II, III, IV, V, and VI in anterior and posterior teeth.
- b. May be used as a direct restorative material and for fabrication of inlays and onlays
TECHNOLOGICAL CHARACTERISTICS: The new COMPOSITE 168 RESTORATIVE SYSTEM is substantially equivalent in composition to the predicate device, K863092 (dental composite restorative).
We believe that the prior use of the components found in COMPOSITE 168 RESTORATIVE SYSTEM in DENTSPLY legally marketed devices support 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 COMPOSITE 168 RESTORATIVE SYSTEM in predicate devices, the performance data provided, and the results of previous biocompatibility testing support the safety and effectiveness of COMPOSITE 168 RESTORATIVE SYSTEM for the intended uses.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1398 FEB
Mr. P. Jeffrey Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
Re: K973221 Composite 168 Restorative System Trade Name: Requlatory Class: II Product Code: EBF Dated: January 28, 1998 Received: January 30, 1998
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 reqistration, 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. ਖੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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
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Page 2 - Mr. Lehn
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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,
the A. Tim Ulatowsk Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
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