Accessories, Implant, Dental, Endosseous
The Accessories, Implant, Dental, Endosseous (product code NDP) are ancillary components used in conjunction with endosseous dental implant systems, such as cover screws, healing abutments, or transfer components. It is classified as an FDA Class 1 device within the Dental specialty, the lowest risk category, subject to general controls and exempt from 510(k) premarket notification. No specific regulation number has been assigned to this product code. The device carries an implant designation and is not flagged as life-sustaining.
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Basic Information
- Product Code
- NDP
- Device Class
- FDA class 1
- Regulation Number
- 872.3980
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K193405 | Simplant Digital Guide | Sep 02, 2020 | Substantially Equivalent | Dentsply Sirona |
| K190059 | CEREC Guides | Sep 27, 2019 | Substantially Equivalent | Dentsply Sirona |
| K170849 | SIMPLANT Guide | Jun 15, 2017 | Substantially Equivalent | Dentsply Sirona |
| K070290 | SPI VECTODRILL CERAMIC DRILLS | Apr 17, 2007 | Substantially Equivalent | Thommen Medical AG |
FEI Numbers
This FDA classification entry is associated with 523 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 523 registration numbers. Click on an entry to view related FDA registrations.