(55 days)
Kerr Corporation, Revolution
Not Found
No
The description focuses on the material composition and physical properties of a dental restorative, with no mention of AI or ML.
No
The device is a dental restorative material (filling material) used for various dental repairs, not a device used for treating diseases or health problems.
No
"Prodigy- 3 is described as a 'flowable, light cure hybrid resin restorative' and 'filling material for Class III, Class IV, and Class V restorations.' Its function is to fill and repair, not to diagnose conditions."
No
The device description clearly states it is a "light cured, hybrid resin dental restorative" and mentions "BIS-GMA chemistry" and "proprietary glass filler," 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 dental restorative material used for filling cavities and other dental procedures. This is a direct treatment applied to the patient's teeth.
- Device Description: The description details the chemical composition and physical properties of the material itself, not a diagnostic test or assay.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Prodigy- 3 is a flowable, light cure hybrid resin restorative designed to be used as a filling material for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.
Product codes
EBF
Device Description
The device is a light cured, hybrid resin dental restorative which incorporates BIS-GMA chemistry along with a proprietary glass filler (approximately 55%) to vield a flowable nonslumping restorative material. Prodigy - 3's combination of flowability and direct application system simplifies material placement and minimizes finishing to result in a consistently superior restoration.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Kerr Corporation, Revolution
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
NOV 1 8 1998
sds K983370
SYBRON DENTAL SPECI Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
September 1998 Date Summary Prepared:
Device Name:
- Trade Name Prodigy 3 .
- Common Name Light-Curable Dental Restorative Material .
- Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690 ●
Devices for Which Substantial Equivalence is Claimed:
- . Kerr Corporation, Revolution
Device Description:
The device is a light cured, hybrid resin dental restorative which incorporates BIS-GMA chemistry along with a proprietary glass filler (approximately 55%) to vield a flowable nonslumping restorative material. Prodigy - 3's combination of flowability and direct application system simplifies material placement and minimizes finishing to result in a consistently superior restoration.
Intended Use of the Device:
The intended use of Prodigy - 3 is for the restoration of Class III, Class IV, and Class V cavities, repair of enamel defects, repair of porcelain restorations, minor occlusal buildups in non-stress bearing areas, sealing pits and fissures, cementing ceramic/composite veneers, incisal abrasions, and core build-ups.
Substantial Equivalence:
Prodigy - 3 is substantially equivalent to other legally marketed devices in the United States. The composite restorative material marketed by Kerr Corporation functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 1998
Ms. Colleen Boswell Senior Regulatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867
K983370 Re : Trade Name: Prodigy - 3 Requlatory Class: II Product Code: EBF Dated: September 23, 1998 September 24, 1998 Received:
Dear Ms. Boswell:
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 Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Ms. Boswell
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
Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section I - Indications for Use
510(k) Number:
Prodigy - 3 Device Name:
Indications for Use:
Prodigy- 3 is a flowable, light cure hybrid resin restorative designed to be used as a filling material for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.
Susan Pupper
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K983370
Prescription Use
(Per 21 CFR 801.109)