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US
Last updated May 24, 2026
Information
- Country
- US
- Address
- —
- Website
- xxx.xxx
- —
- —
- [email protected]
- Phone
- +1(760)743-7744
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 601302743
Catalogue (260)
Page 5 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Microetcher | 93825 | FDA UDI | Class II | Active |
| Turbo Temp 2 | 90343 | FDA UDI | Class II | Active |
| First Quarter | 89277 | FDA UDI | Class II | Active |
| Accolade | 90840 | FDA UDI | Class II | Active |
| Sky Select | KY9029 | FDA UDI | Class II | Active |
| Start Vps | 80060-01 | FDA UDI | Class II | Active |
| Prelude | 90994 | FDA UDI | Class II | Active |
| Prelude | 94036 | FDA UDI | Class II | Active |
| Fusion | FHA | FDA UDI | Class II | Active |
| Fusion | FBFS2 | FDA UDI | Class II | Active |
| Start Vps | 80009-01 | FDA UDI | Class II | Active |
| Contact Matrix | 91715 | FDA UDI | Class I | Active |
| Accolade Sro | 93830 | FDA UDI | Class II | Active |
| Royal | 81016 | FDA UDI | Class II | Active |
| Startflow | 90749 | FDA UDI | Class II | Active |
| Siljet | 93596 | FDA UDI | Class II | Active |
| Start Vps | 80014-01 | FDA UDI | Class II | Active |
| First Quarter | 90900 | FDA UDI | Class II | Active |
| Sky Select | KY9027 | FDA UDI | Class II | Active |
| First Quarter | 80008-01 | FDA UDI | Class II | Active |
| Sure Etch | 89463 | FDA UDI | Class II | Active |
| Microprime | 94263 | FDA UDI | Class II | Active |
| Accolade Pv | 91216 | FDA UDI | Class II | Active |
| Accolade | 90549 | FDA UDI | Class II | Active |
| Accolade | 90548 | FDA UDI | Class II | Active |
| Viax | 94944 | FDA UDI | Class II | Active |
| Accolade Pv | 90560 | FDA UDI | Class II | Active |
| Fusion | FTXA2 | FDA UDI | Class II | Active |
| Accolade Pv | 91232 | FDA UDI | Class II | Active |
| Contact Matrix | 91476 | FDA UDI | Class I | Active |
| Aria | 89362 | FDA UDI | Class II | Active |
| Prepstart | 200259-00 | FDA UDI | Class II | Active |
| Turbo Temp 2 | 91087 | FDA UDI | Class II | Active |
| Accolade | 90547 | FDA UDI | Class II | Active |
| Aria | 89363 | FDA UDI | Class II | Active |
| Accolade Pv | 91234 | FDA UDI | Class II | Active |
| Sdi | 410-5002 | FDA UDI | Class II | Active |
| Sky Select | KY9025 | FDA UDI | Class II | Active |
| Viax | 94943 | FDA UDI | Class II | Active |
| Fusion | FTXB1 | FDA UDI | Class II | Active |
| Viax | 94968 | FDA UDI | Class II | Active |
| Contact Matrix | 90679 | FDA UDI | Class I | Active |
| Contact Matrix | 90070 | FDA UDI | Class I | Active |
| Prestige | K151514 | FDA 510(k) | Class II | Active |
| DMRC Bulk Fill | K151088 | FDA 510(k) | Class II | Active |
| Z Bond, Prelude One | K111876 | FDA 510(k) | Class II | Active |
| Star Vps, Model 80014-01, First Quater, Model 90649, First Half, Model 89387 | K092319 | FDA 510(k) | Class II | Active |
| Prepair | K033215 | FDA 510(k) | Class II | Active |
| Starflow Hv | K020760 | FDA 510(k) | Class II | Active |
| Siljetr System | K110642 | FDA 510(k) | Class II | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 24, 2016 | Z-2530-2016 | — | terminated | The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim. |