(60 days)
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Not Found
No
The summary describes a computer-aided design and milling system for dental restorations, but there is no mention of AI or ML in the intended use, device description, or any other section.
No
The device is used for designing and milling dental restorations, which are replacement structures, not a treatment for disease or injury.
No
The device is used for the computer-aided design and milling of dental restorations, which is a treatment or restorative function, not a diagnostic one.
No
The intended use explicitly mentions "milling of ceramic dental restorations," which is a hardware-based process. The summary does not provide information suggesting the device is solely software controlling an external milling machine.
Based on the provided information, the CEREC® 3 System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "computer-aided design and milling of ceramic dental restorations." This describes a process performed outside the body, but it's focused on creating a physical dental restoration, not on analyzing biological samples to diagnose a condition.
- 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 diagnostic information about a patient's health status
- Using reagents or assays
- Measuring biomarkers
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CEREC® 3 System's function is to fabricate dental prosthetics, which falls outside this definition.
N/A
Intended Use / Indications for Use
The CEREC® 3 System is intended to be used in the computer-aided design and milling of ceramic dental restorations, including inlays, onlays, veneers, partial crowns, and full crowns.
Product codes
ELW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three parallel lines above them.
Public Health Service
8 2000 FEB
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sirona Dental Systems, GmbH c/o Ms. Sheila Hemeon-Heyer Sirona Dental Systems, GmbH MDCI Consultants 49 Plain Street North Attleboro, Massachusetts
Re : K994172
CEREC® 3 Ceramic Dental Restoration System Trade Name: Requlatory Class: II Product Code: ELW Dated: January 7, 2000 Received: January 10, 2000
Dear Ms. Hemeon-Heyer:
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. ಗಿ 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
1
Page 2 - Ms. Hemeon-Heyer
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.
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,
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
K994172 510(k) Number (if known):
Device Name: CEREC® 3 CERAMIC DENTAL RESTORATION SYSTEM
Indications For Use:
The CEREC® 3 System is intended to be used in the computer-aided design and milling of ceramic dental restorations, including inlays, onlays, veneers, partial crowns, and full crowns.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Beadle W. Shipp
(Division Sign-Off) Consion of Dental, Infection Control, oneral Hospital Devices traber _ ાર વેવ
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Sirona Dental Systems GmbH Special 510(k) CEREC® 3 Ceramic Dental Restoration System 12/09/99
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