BruxZir®
BruxZir® NOW SRC for Inclusive® Tapered Implant System Ø 3.7/4.2 mm, Bleach White
2manufacturers in China registered for this device type
62catalogue 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 | Prismatik Dentalcraft, Inc., United States |
|---|---|
| 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 |
| 510(k) | K231940 |
| Record published | 2024-11-08 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 70-1185-NOW0129 | In distribution | |
| 70-1185-NOW0041 | In distribution | |
| 70-1185-NOW0110 | In distribution | |
| 70-1185-NOW0102 | In distribution | |
| 70-1185-NOW0073 | In distribution | |
| 70-1185-NOW0119 | In distribution | |
| 70-1185-NOW0104 | In distribution | |
| 70-1185-NOW0113 | In distribution | |
| 70-1185-NOW0030 | In distribution | |
| 70-1185-NOW0031 | In distribution | |
| 70-1185-NOW0092 | In distribution | |
| 70-1185-NOW0098 | In distribution | |
| 70-1185-NOW0074 | In distribution | |
| 70-1185-NOW0117 | In distribution | |
| 70-1185-NOW0060 | In distribution | |
| 70-1185-NOW0048 | In distribution | |
| 70-1185-NOW0106 | In distribution | |
| 70-1185-NOW0071 | In distribution | |
| 70-1185-NOW0037 | In distribution | |
| 70-1185-NOW0065 | In distribution | |
| 70-1185-NOW0040 | In distribution | |
| 70-1185-NOW0035 | In distribution | |
| 70-1185-NOW0100 | In distribution | |
| 70-1185-NOW0057 | In distribution | |
| 70-1185-NOW0043 | In distribution | |
| 70-1185-NOW0127 | In distribution | |
| 70-1185-NOW0114 | In distribution | |
| 70-1185-NOW0125 | In distribution | |
| 70-1185-NOW0069 | In distribution | |
| 70-1185-NOW0124 | In distribution | |
| 70-1185-NOW0062 | In distribution | |
| 70-1185-NOW0115 | In distribution | |
| 70-1185-NOW0068 | In distribution | |
| 70-1185-NOW0109 | In distribution | |
| 70-1185-NOW0090 | In distribution | |
| 70-1185-NOW0044 | In distribution | |
| 70-1185-NOW0063 | In distribution | |
| 70-1185-NOW0097 | In distribution | |
| 70-1185-NOW0081 | In distribution | |
| 70-1185-NOW0095 | In distribution | |
| 70-1185-NOW0053 | In distribution | |
| 70-1185-NOW0066 | In distribution | |
| 70-1185-NOW0120 | In distribution | |
| 70-1185-NOW0079 | In distribution | |
| 70-1185-NOW0105 | In distribution | |
| 70-1185-NOW0133 | In distribution | |
| 70-1185-NOW0126 | In distribution | |
| 70-1185-NOW0028 | In distribution | |
| 70-1185-NOW0077 | In distribution | |
| 70-1185-NOW0038 | In distribution | |
| 70-1185-NOW0076 | In distribution | |
| 70-1185-NOW0080 | In distribution | |
| 70-1185-NOW0029 | In distribution | |
| 70-1185-NOW0032 | In distribution | |
| 70-1185-NOW0049 | In distribution | |
| 70-1185-NOW0033 | In distribution | |
| 70-1185-NOW0107 | In distribution | |
| 70-1185-NOW0050 | In distribution | |
| 70-1185-NOW0123 | In distribution | |
| 70-1185-NOW0020 | In distribution | |
| 70-1185-NOW0132 | In distribution | |
| 70-1185-NOW0086 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IPD | Implant Protesis Dental 2004 SL | 317 |
| 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 |
| AbutmentCAD | Exocad Gmbh | 4 |
Showing 12 of 19. All products under Dental Abutment Design Software For Dental Laboratory
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231529 | 2024-03-14 |
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.