(64 days)
None
Not Found
No
The summary describes a dental impression material, which is a physical substance, and contains no mention of AI, ML, or any computational processing.
No
The device is a dental impression material used to create molds of teeth, which is a diagnostic/measurement purpose rather than a therapeutic one.
No
The device is described as a dental impression material used to make impressions of teeth, which is a manufacturing or procedural tool, not a diagnostic one. It does not identify or characterize a disease or condition.
No
The device is described as a "dental impression material," which is a physical substance used to create a mold of teeth. This is a hardware component, not software.
Based on the provided information, Zhermack COLORBITE is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to take an impression of a patient's teeth. This is a physical process for creating a mold, not a diagnostic test performed on a sample taken from the body.
- Device Description: It's described as a dental impression material, which aligns with its intended use.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information about a patient's health condition.
IVDs are typically used to examine specimens (like blood, urine, tissue) to diagnose diseases or conditions. Zhermack COLORBITE is a tool used in a dental procedure for creating a physical replica.
N/A
Intended Use / Indications for Use
Zhermack COLORBITE is a dental impression material indications Tor 650. of a patient's teeth.
Product codes
ELW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's teeth
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
§ 872.3660 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
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2006 MAR J
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zhermack S.P.A. C/O Mr. Gerald W. Shipps Regulatory Affairs Consultant Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702
Re: K053619
Trade/Device Name: Colorbite Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: December 27, 2005 Received: December 27, 2005
Dear Mr. Shipps:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
1
Page 2 - Mr. Gerald W. Shipps
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Susan Lyons
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital , Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE 2
175 3619 510(k) Number (if known): _
Device Name: COLORBITE
Indications for Use: Zhermack COLORBITE is a dental impression material indications Tor 650.
of a patient's teeth.
Prescription Use
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Susan Pearson
Shippings, General Huspisci, met. Dental Dovices
KC5 3619
COLORBITE Rev. 0 Julyl, 01 2005