Preat
NobelBiocare™ Tri-Lobe-compatible 6.0 mm Titanium Blank Kit contains 1 NobelBiocare™ Tri-Lobe-compatible 6.0 mm Titanium Blank. 2 NobelBiocare™ Tri-Lobe-compatible RP/5.0mm/6.0mm Titanium…
NobelBiocare™ Tri-Lobe-compatible 6.0 mm Titanium Blank Kit contains 1 NobelBiocare™ Tri-Lobe-compatible 6.0 mm Titanium Blank. 2 NobelBiocare™ Tri-Lobe-compatible RP/5.0mm/6.0mm Titanium Implant Screws
2manufacturers in China registered for this device type
46catalogue numbers in this listing
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 | Preat Corporation, 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 | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K183518 |
| Record published | 2025-06-10 |
| Record revised | 2025-06-27 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Inner pack |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9005765 | In distribution | |
| 9000265 | In distribution | |
| 9006665 | In distribution | |
| 9001865 | In distribution | |
| 9002265 | In distribution | |
| 9005965 | In distribution | |
| 9004165 | In distribution | |
| 9006865 | In distribution | |
| 9007565 | In distribution | |
| 9001565 | In distribution | |
| 9000465 | In distribution | |
| 9005065 | In distribution | |
| 9007165 | In distribution | |
| 9008565 | In distribution | |
| 9000865 | In distribution | |
| 9000165 | In distribution | |
| 9006465 | In distribution | |
| 9005365 | In distribution | |
| 9001765 | In distribution | |
| 9000767 | In distribution | |
| 9006765 | In distribution | |
| 9001965 | In distribution | |
| 9006565 | In distribution | |
| 9000765 | In distribution | |
| 9000565 | In distribution | |
| 9000567 | In distribution | |
| 9000965 | In distribution | |
| 9001665 | In distribution | |
| 9007265 | In distribution | |
| 9002165 | In distribution | |
| 9000365 | In distribution | |
| 9005465 | In distribution | |
| 9004765 | In distribution | |
| 9000667 | In distribution | |
| 9005265 | In distribution | |
| 9005665 | In distribution | |
| 9004465 | In distribution | |
| 9002065 | In distribution | |
| 9001465 | In distribution | |
| 9000665 | In distribution | |
| 9005565 | In distribution | |
| 9005865 | In distribution | |
| 9001265 | In distribution | |
| 9000467 | In distribution | |
| 9005165 | In distribution | |
| 9007065 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IPD | Implant Protesis Dental 2004 SL | 317 |
| BruxZir® | Prismatik Dentalcraft, Inc. | 62 |
| 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
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Preat Corporation | 510(k) number | 2025-06-25 | Class II | Process control | Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correc | 11 |
| Preat Corporation | 510(k) number | 2025-04-02 | Class II | Process control | Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant. | 145 abutments |
| Preat Corporation | 510(k) number | 2024-02-09 | Class II | Process change control | Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant. | 561 units |
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.