Dental Abutment Design Software for Dental Laboratory
Universal Base External Hex Connection RP 1.5mm
2manufacturers in China registered for this device type
7catalogue 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 | 2021-09-23 |
| Record revised | 2025-11-21 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 301108 | Height 1.500 mm | In distribution |
| 301112 | Height 3.000 mm | In distribution |
| 301110 | Height 3.000 mm | In distribution |
| 301111 | Height 3.000 mm | In distribution |
| 301105 | RP | In distribution |
| 301104 | Height 3.000 mm | In distribution |
| 301107 | NP | 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 |
| Nobel Biocare N1™ | Nobel Biocare AB | 10 |
| CAD/CAM Software | Sirona Dental Systems Gmbh | 9 |
| 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.