Nobel Biocare N1™
Universal Abutment Nobel Biocare N1™ Base Tri NP Bridge
2manufacturers in China registered for this device type
10catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Exceldent Dental Technology Development Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 12 |
| Shimmer Computerized Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 10 |
Record
| Listed by | Nobel Biocare AB, Sweden |
|---|---|
| FDA product code | PNP |
| Device type | Dental Abutment Design Software For Dental Laboratory |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2022-01-26 |
| Record revised | 2025-07-07 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight. Keep dry |
| Sizes | Height 1.5 to 3 mm; outer diameter 10 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 301007 | In distribution | |
| 300946 | Height 1.500 mm | In distribution |
| 301009 | In distribution | |
| 300948 | Height 1.500 mm | In distribution |
| 300947 | Height 3.000 mm | In distribution |
| 301007 | In distribution | |
| 301006 | In distribution | |
| 300946 | Height 1.500 mm | In distribution |
| 301009 | In distribution | |
| 301511 | Outer Diameter 10.000 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IPD | Implant Protesis Dental 2004 SL | 317 |
| BruxZir® | Prismatik Dentalcraft, Inc. | 62 |
| Preat | Preat Corporation | 46 |
| MEDENTiKA | Medentika GmbH | 36 |
| Cerec Tessera | Degudent Gmbh | 15 |
| BioHorizons | Biohorizons Implant Systems Inc. | 10 |
| CAD/CAM Software | Sirona Dental Systems Gmbh | 9 |
| Dental Abutment Design Software For Dental Laboratory | Nobel Biocare AB | 7 |
| Cerec | Degudent Gmbh | 6 |
| Preat Implant Prosthetics | Preat Corporation | 4 |
| DTX Studio™ Lab | Nobel Biocare AB | 4 |
| AbutmentCAD | Exocad Gmbh | 4 |
Showing 12 of 19. All products under Dental Abutment Design Software For Dental Laboratory
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181932 | 2019-03-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.