(35 days)
None
Not Found
No
The summary describes a light-activated hybrid composite for dental restorations and does not mention any AI or ML components or functionalities.
No
The device is a light-activated hybrid composite used for dental restorations, which is a material used in therapy rather than a therapeutic device that actively treats a condition itself.
No
The device is described as a "Light activated hybrid composite" used for restorative dental procedures, such as fillings and cementation. It is a material used for treatment, not for diagnosing conditions.
No
The device description explicitly states it is a "Light activated hybrid 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 uses listed are all related to dental restorative procedures performed directly on a patient's teeth. This involves treating the patient's body, not analyzing samples taken from the body.
- Device Description: The device is described as a "Light activated hybrid composite," which is a material used for filling cavities and restoring teeth. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Using reagents or assays.
In summary, this device is a dental restorative material used for direct treatment of a patient's teeth, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
- Class V restorations (cervical caries, root erosion, wedge shaped defects)
- Anterior restorations (Class III and IV)
- Small posterior restorations
- Restorative therapy for mini-cavities, of all types (preparation with -Sonic-Sys Micro Instruments from KaVo-)
- Adhesive cementation of Sonic-Sys Inlays
- Extended fissures sealings in molars and pre-molars
- Repair of composite/ceramic veneers
- Blocking out of undercuts
- Adhesive cementation of ceramic and composite restorations
Product codes
EBF
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
§ 872.3690 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/1 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 1999
Mr. Peter P. Mancuso Requlatory/Quality Assurance Manager Ivoclar North America, Inc. 175 Pineview Drive Amherst, NY 14228
Re : K993783 Light activated hybrid composite Trade Name: Requlatory Class: II Product Code: EBF November 3, 1999 Dated: Received: November 8, 1999
Dear Mr. Mancuso:
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, qood 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. A 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 regulation 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
1
Page 2 - Mr. Mancuso
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.
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 diaqnostic 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
2
CONFIDENTIAL
Image /page/2/Picture/1 description: The image shows a sequence of digits and a letter. The sequence starts with the letter 'K', followed by the digits '93703'. The characters are bold and black, contrasting with the white background. The style of the characters appears to be hand-drawn or stylized.
Page
510(k) Number (if known): |(993783
Tetric Flow Device Name:
Indications For Use:
- Class V restorations (cervical caries, root erosion, wedge shaped defects) 1
- -Anterior restorations (Class III and IV)
- Small posterior restorations -
- Restorative therapy for mini-cavities, of all types (preparation with -Sonic-Sys Micro Instruments from KaVo-)
- Adhesive cementation of Sonic-Sys Inlays
- -Extended fissures sealings in molars and pre-molars
- -Repair of composite/ceramic veneers
- । Blocking out of undercuts
- -Adhesive cementation of ceramic and composite restorations
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Susan Runner
(Division Sign-Off) Division of Dental, Infection O and General Hospital De 510(k) Number