Tube Impression And Matrix
A tube impression and matrix device is a dental accessory used to create precise impressions of the oral cavity, particularly in relation to dental prosthetics and appliance fitting, by forming a mold or template of the tooth and surrounding structures. It is classified as an FDA Class 1 device, the lowest risk tier, subject only to general controls. Product code KCQ is regulated under 21 CFR 872.6570 in the Dental medical specialty. This device is GMP exempt, meaning it is not subject to full Quality System Regulation requirements.
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Basic Information
- Product Code
- KCQ
- Device Class
- FDA class 1
- Regulation Number
- 872.6570
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K896621 | L.T.C. REPLACEMENT GASTROSTOMY TUBE | Mar 13, 1990 | Substantially Equivalent | Intl. Medical Marketing, Inc. |
FEI Numbers
This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.