(43 days)
Not Found
No
The 510(k) summary describes a dental composite material, which is a passive restorative material and does not involve any computational or analytical functions typically associated with AI/ML. The summary also explicitly states "Not Found" for mentions of AI, DNN, or ML, and lacks descriptions of training/test sets or performance metrics relevant to AI/ML algorithms.
No
The device is a restorative material used to fill cavities in teeth, which restores function and structure rather than providing therapy for a disease or condition.
No
This device is described as a "dental composite restorative material," which implies it is used for treatment (restoration of cavities), not for diagnosing conditions.
No
The device description clearly states it is a "visible light cured dental composite restorative material," which 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 is to be a dental composite restorative material for filling cavities 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 cured dental composite restorative material. This is a material used for physical restoration.
- Anatomical Site: The anatomical site is teeth (cavities), which are part of the human body.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the body (like blood, urine, tissue) to diagnose a condition, monitor a disease, or screen for health issues.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used in vivo (within the body) for restorative purposes.
N/A
Intended Use / Indications for Use
Prodigy 2 is a dental composite restorative material intended to be used in Class II cavities. It may also be used in all classes of cavities wherever an additional resistance to pack is deemed necessary.
Product codes
EBF
Device Description
The device is a visible light cured dental composite restorative material. Due to the material's unique handling characteristics, Prodigy 2 is suggested for use in Class I and Class II cavity situations. However, Prodigy 2 may also be used in all classes of cavities, wherever an additional resistance to pack is deemed necessary.
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)
Not Found
Reference Device(s)
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
Image /page/0/Picture/2 description: The image shows the logo for Sybron Dental Specialties, Inc. The word "SYBRON" is in large, bold, sans-serif font. Below it, in a smaller, but still bold, sans-serif font, are the words "DENTAL SPECIALTIES, INC."
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
Date Summary Prepared: June 1998
Device Name:
- Trade Name Prodigy 2 .
- Common Name Dental Composite Restorative Material .
- Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690 ●
Devices for Which Substantial Equivalence is Claimed:
- Heraeus Kulzer, Inc., Solitaire® .
- Jeneric/Pentron Inc., Alert .
- Dentsply/Caulk, a division of Dentsply International Inc., SureFil™ .
Device Description:
The device is a visible light cured dental composite restorative material. Due to the material's unique handling characteristics, Prodigy 2 is suggested for use in Class I and Class II cavity situations. However, Prodigy 2 may also be used in all classes of cavities, wherever an additional resistance to pack is deemed necessary.
Intended Use of the Device:
The intended use of Prodigy 2 is for use in Class II cavities. It may also be used in all classes of cavities wherever an additional resistance to pack is deemed necessary.
Substantial Equivalence:
Prodigy 2 is substantially equivalent to several other legally marketed devices in the United States. The dental composite restoratives marketed by Heraeus Kulzer, Inc., Jeneric/Pentron Inc. and Dentsply/Caulk, a division of Dentsply International Inc., function in a manner similar to and are intended for the same use as the product manufactured by Kerr Dental Materials Center.
Printed on Recycled Paper
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Image /page/1/Picture/2 description: The image shows a partial logo of the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with healthcare, with three intertwined strands. The word "DEPARTMENT" is partially visible along the left side of the image, indicating the logo's origin.
JUL 31 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Colleen Boswell Manager, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867
Re : K982148 Trade Name: Prodigy 2 Regulatory Class: II Product Code: EBF June 17, 1998 Dated: Received: June 18, 1998
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 regulations 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 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 the Federal Reqister. 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.
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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 regulation (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,
S. Butman for
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: K982148
Prodigy 2 Device Name:
Indications for Use:
Prodigy 2 is a dental composite restorative material intended to be used in Class I Prodity 2 is a deman composite reserved in all classes of cavities wherever an additional resistance to pack is deemed necessary.
Susan Runoe
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K950215