Definition: An Optical Impression System For Cad/cam Of Dental Restorations Is A Device Used To Record The Topographical Characteristics Of Teeth, Dental Impressions, Or Stone Models By Analog Or Digital Methods For Use In The Computer Aided Design And Manufactu
| Device Type ID | 1346 |
| Device Name | System, Optical Impression, Computer Assisted Design And Manufacturing (cad/cam) Of Dental Restorations |
| Regulation Description | Optical Impression Systems For CAD/CAM. |
| 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 | 872.3661 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NOF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 1346 |
| Device | System, Optical Impression, Computer Assisted Design And Manufacturing (cad/cam) Of Dental Restorations |
| Product Code | NOF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Optical Impression Systems For CAD/CAM. |
| CFR Regulation Number | 872.3661 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ORMCO CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYBRON DENTAL SPECIALTIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 9 |
Electrical Power Problem | 4 |
Environmental Compatibility Problem | 4 |
Appropriate Term/Code Not Available | 2 |
Use Of Device Problem | 1 |
Fracture | 1 |
Device Operational Issue | 1 |
Flammable | 1 |
CPU (Central Processing Unit) Board | 1 |
| Total Device Problems | 24 |