Ink, Arch Tracing
The Arch Tracing Ink is a dental material used in the recording of mandibular movement and occlusal contact patterns by applying ink to tracing devices or registration materials, supporting the diagnosis and treatment planning of temporomandibular joint conditions and prosthetic restorations. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, and is exempt from Good Manufacturing Practice (GMP) requirements. The product code is KZO, regulated under 21 CFR 872.3150, in the Dental medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- KZO
- Device Class
- FDA class 1
- Regulation Number
- 872.3150
- 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 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.