Definition: For The Fabrication Of Preformed Denture Teeth For Use In A Denture Base
| Device Type ID | 1389 |
| Device Name | Additively Manufactured, Preformed, Resin Denture Tooth |
| Physical State | Resin. |
| Technical Method | Digital Patient Scan Is Used In Conjunction With Software And A 3D Printer To Build Patient-matched Denture Teeth By Depositing Layer Upon Layer Of The Resin Material. |
| Target Area | Intraoral. |
| Regulation Description | Preformed Plastic Denture Tooth. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 872.3590 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PZY |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1389 |
| Device | Additively Manufactured, Preformed, Resin Denture Tooth |
| Product Code | PZY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Preformed Plastic Denture Tooth. |
| CFR Regulation Number | 872.3590 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DENTCA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |