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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 30 Bearfoot Rd, Northborough, MA, 01532
- Website
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- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2431866
- DUNS Number
- —
Catalogue (31)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OsteoGen Plugs - Large, 10x20mm | OPL1020 | FDA UDI | Class II | Active |
| TriStar Screws - 5mm (Pack of 5) | TRI-05 | FDA UDI | Class II | Active |
| OsteoGen Plugs - Slim, 6x25mm | OPS625 | FDA UDI | Class II | Active |
| TriStar Screws - 24mm (Pack of 5) | TRI-24 | FDA UDI | Class II | Active |
| OsteoGen Strip - Small | OSS12203 | FDA UDI | Class II | Active |
| TriStar Screws - 15mm (Pack of 5) | TRI-15 | FDA UDI | Class II | Active |
| OsteoGen Block | OBB101517 | FDA UDI | Class II | Active |
| OsteoGen - 3.0g / 6.0cc Vial | 200-150 | FDA UDI | Class II | Active |
| TriStar Screws - 10mm (Pack of 5) | TRI-10 | FDA UDI | Class II | Active |
| OsteoGen Strip | OSL20403 | FDA UDI | Class II | Active |
| OsteoGen - 1.5g / 3.0cc Vial | 200-150 | FDA UDI | Class II | Active |
| TriStar Screws - 3mm (Pack of 5) | TRI-03 | FDA UDI | Class II | Active |
| TriStar Screws - 8mm (Pack of 5) | TRI-08 | FDA UDI | Class II | Active |
| OsteoGen Pre-Filled Syringe - 0.3g / 0.6cc | OG-SYR | FDA UDI | Class II | Active |
| TriStar Screws - 14mm (Pack of 5) | TRI-14 | FDA UDI | Class II | Active |
| OsteoGen - 0.75g / 1.5cc Vial | 200-075 | FDA UDI | Class II | Active |
| TriStar Screws - 18mm (Pack of 5) | TRI-18 | FDA UDI | Class II | Active |
| TriStar Screws - 12mm (Pack of 5) | TRI-12 | FDA UDI | Class II | Active |
| TriStar Screws - 21mm (Pack of 5) | TRI-21 | FDA UDI | Class II | Active |
| TriStar Screws - 4mm (Pack of 5) | TRI-04 | FDA UDI | Class II | Active |
| TriStar Screws - 6mm (Pack of 5) | TRI-06 | FDA UDI | Class II | Active |
| OsteoGen Plugs - Extra Large | OPXL1520 | FDA UDI | Class II | Active |
| Osteogen | K843398 | FDA 510(k) | Class II | Active |
| Laminoss Dental Implant | K933705 | FDA 510(k) | Class II | Active |
| Expanded Claimes To Osteogen(r) | K881662 | FDA 510(k) | Class II | Active |
| Flexi-Cup Implant | K792663 | FDA 510(k) | Class II | Active |
| Tristar Bone Graft Fixation System | K141764 | FDA 510(k) | Class II | Active |
| Osteogen Sbrg | K033098 | FDA 510(k) | Class II | Active |
| Hydroxi-Flex Implant | K812321 | FDA 510(k) | Class II | Active |
| Laminoss Dental Implant | K982925 | FDA 510(k) | Class II | Active |
| Osteogen (ha Resorb) | K923310 | FDA 510(k) | Class II | Active |
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