| Device |
dental abutment design software for dental laboratory |
| Regulation Description |
Endosseous dental implant abutment. |
| 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 component at a dental office or dental laboratory following the directions of the dental implant system. The abutment-to-implant interface/connection platform is not a patient-specific component of the dental abutment. |
| 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 dental abutment (i.e. abutment collar and abutment post). The abutment-to-implant interface/connection platform is not a patient-specific component of the dental abutment. |
| Target Area |
oral environment |
| Regulation Medical Specialty |
Dental |
| Review Panel |
Dental |
|---|
| Product Code | PNP |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
872.3630
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standard
|
| Third Party Review |
Not Third Party Eligible |
