Cerec
Primescan AC with touch pad, steel window sleeve, Special Edition for SDC (Smile Direct Club)
2manufacturers in China registered for this device type
1catalogue number
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 | Sirona Dental Systems Gmbh, Germany |
|---|---|
| FDA product code | PNP |
| Device type | Dental Abutment Design Software For Dental Laboratory |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2019-09-17 |
| Record revised | 2023-04-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | High-level Disinfectant |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6729615 | 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 |
| 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 |
Showing 12 of 19. All products under Dental Abutment Design Software For Dental Laboratory
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.