(58 days)
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No
The summary describes a system for optical impression, computer-aided design, and milling of dental restorations. There is no mention of AI or ML in the intended use, device description, or any other section. The focus is on extending existing capabilities for full crowns.
No
The device is used for the design and milling of dental restorations, which is a manufacturing process, not a therapeutic intervention on a patient.
No
The device is used for obtaining an optical impression for computer-aided design and milling of dental restorations, not for diagnosing medical conditions.
No
The device is described as software that is a modification of a system that includes a 3D camera for optical impressions and a milling machine. While the submission focuses on the software modification, the overall system is not software-only.
Based on the provided information, the Cerec 2 Crown Software is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of the Cerec 2 Crown Software is to obtain an optical impression of a patient's mouth and then design and mill dental restorations. This process does not involve analyzing biological samples like blood, urine, or tissue.
- The device description and intended use clearly focus on dental restoration. The system is used for creating inlays, veneers, partial crowns, and full crowns based on an optical impression of the patient's teeth.
Therefore, the Cerec 2 Crown Software falls under the category of a dental device used for restorative procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Cerec 2 Crown Software is a modification of the Cerec 2 Dicor Dental Restoration System. The Cerec 2 System is used to obtain an optical impression using a threedimensional camera. The optical impression is used in the computer-aided design and milling of ceramic restorations including inlays, veneers and partial crowns. The modifications extend the capabilities to include 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
optical impression using a threedimensional camera
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/2 description: The image shows a logo for the Department of Health. The logo features a stylized depiction of a human head in profile, with three overlapping silhouettes suggesting a sense of community or interconnectedness. The words "DEPARTMENT OF HEALTH &" are arranged vertically along the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steven A. Clarke, RAC Staff Consultant Siemens AG C/O Medical Device Consultants, Incorporated 49 Plain Street 02760 North Attleboro, Massachusetts
AUG 1 5 1997
Re: K972276 Cerac 2 Crown Software Trade Name: Requlatory Class: II Product Code: ELW Dated: June 17, 1997 Received: June 18, 1997
Dear Mr. Clarke:
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 Regulations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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
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Page 2 - Mr. Clarke
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) 594-4618. 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,
Timothy Ulatowski
Timothy A Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): _ K972276
Device Name: Cercc 2 Crown Software
Indications For Use:
The Cerec 2 Crown Software is a modification of the Cerec 2 Dicor Dental Restoration System. The Cerec 2 System is used to obtain an optical impression using a threedimensional camera. The optical impression is used in the computer-aided design and milling of ceramic restorations including inlays, veneers and partial crowns. The modifications extend the capabilities to include full crowns.
(Please do not write below this line - continue on another page if necessary)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susar Runver
(Division Sign-Off)
Division of Dontal, Infection Control. and General Hospital Devi 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use No
Cerec 2 Crown Software 510(k)
June 17, 1997
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