(117 days)
Not Found
PCCP
No
The document describes a dental composite material and bonding system, with no mention of software, algorithms, or any technology related to AI or ML.
No.
The device is a dental composite used for fillings and reconstruction, which is a restorative material rather than a therapeutic device designed to treat a disease or condition.
No
Explanation: The device, Solitaire, is described as a composite material used for fillings, reconstruction, and stump rebuilding. Its intended uses (e.g., "Class I & II Cavities," "Class V Fillings") indicate it is a therapeutic or restorative material, not a diagnostic one. It does not identify or detect diseases or conditions.
No
The device description clearly states it is a "light-curing, fluoride releasing radiopaque polyglas composite," 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 describes the device as a dental composite for filling cavities and rebuilding tooth structures. This is a direct treatment applied to the patient's teeth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description confirms it's a dental material (composite).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, Solitaire is a medical device used in dentistry for restorative procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Solitaire is a light-curing, fluoride releasing radiopaque polyglas sements - Tecarber with the Solid bond adhesive bonding system, it is composite. Together with the Solid bond adhesive bonding system, it is composite. Together with the Still Come Can't
- Class I & II (Black) Cavities
- Class V Fillings (Black)
- Deciduous Tooth Reconstruction
- Stump Rebuilding
Product codes
KLE
Device Description
Not Found
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)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
Image /page/0/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 eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written along the border of the circle. The eagle is composed of three curved lines that suggest movement and flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Cheryl V. Zimmerman Manager, Quality Assurance & Regulatory Affairs Heraeus Kulzer, Incorporated Dental Products Division 4315 South Lafayette Boulevard South Bend, Indiana 46614-2517
SEP 2 9 1997
K972101 Re : Solitaire Trade Name: Requlatory Class: II Product Code: KLE Dated: Auqust 1, 1997 Received: August 7, 1997 ...
Dear Ms. Zimmerman:
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. ಡಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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
1
Page 2 - Ms. Zimmerman
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,
Time y A. Ulatowsk Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
2
29, 67 63, 88 28:28PT ======================================================================================================================================================================
Page L of L
Sublic - International Cong
510(k) Number (if known): K972101
Device Name:_ Solitaire
Indications For Use:
Solitaire is a light-curing, fluoride releasing radiopaque polyglas
sements - Tecarber with the Solid bond adhesive bonding system, it composite. Together with the Solid bond adhesive bonding system, it is composite. Together with the Still Come Can't
- Class I & II (Black) Cavities - Class V Fillings (Black) - Deciduous Tooth Reconstruction - Stump Rebuilding
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sween Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number _
y u Prescription Use (Per 21 CFR 801.109)
OR ·
Over-The-Counter Use No
(Optional Format 1-2-96)
3