Definition: The Device Is Intended To Aid In The Restoration Of Chewing Function By Allowing A Dental Laboratory Or Dental Clinician To Design The Patient-specific Component Of A Dental Abutment (i.e. Abutment Collar And Abutment Post) And CAM Or Create That Com
| Device Type ID | 1386 |
| Device Name | Dental Abutment Design Software For Dental Laboratory |
| Physical State | Device Is Composed Of Software Contained In A Standard Desktop Computer, Stand-alone Computer Unit, Or Online Software, An Intra- Or Extra-oral Scanner, And A CAM Unit. |
| Technical Method | The Device Utilizes A Digital Image/impression Of The Patient's Oral Environment For The Purpose Of Designing And Creating A Dental Abutment. The Device Uses A Validated CAM Unit To Create A Physical Version Of The Patient Specific Component Of The D |
| Target Area | Oral Environment |
| Regulation Description | Endosseous Dental Implant Abutment. |
| 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) |
| CFR Regulation Number | 872.3630 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PNP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1386 |
| Device | Dental Abutment Design Software For Dental Laboratory |
| Product Code | PNP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endosseous Dental Implant Abutment. |
| CFR Regulation Number | 872.3630 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
3SHAPE A/S | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NOBEL BIOCARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NOBEL BIOCARE AB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |