Additively Manufactured, Preformed, Resin Denture Tooth
The Additively Manufactured, Preformed, Resin Denture Tooth is a dental device fabricated using additive manufacturing (3D printing) techniques, intended for use as preformed teeth in the construction of complete or partial denture bases. It is classified as a Class 2 device under regulation 872.3590, requiring 510(k) premarket notification or De Novo classification, and falls within the Dental (DE) medical specialty. The product code is PZY. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PZY
- Device Class
- FDA class 2
- Regulation Number
- 872.3590
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
Definition
For the fabrication of preformed denture teeth for use in a denture base
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 |
|---|---|---|---|---|
| K172398 | DENTCA DENTURE Teeth | Nov 22, 2017 | Substantially Equivalent | Dentca, Inc. |
FEI Numbers
This FDA classification entry is associated with 46 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 46 registration numbers. Click on an entry to view related FDA registrations.