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US
Last updated May 23, 2026
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 276075371
Catalogue (559)
Page 1 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Engine Reamers | n015 L21 | FDA UDI | Class I | Active |
| 2Shape | TS2 n25 6% L25 | FDA UDI | Class I | Active |
| K-Files | N070 L31 | FDA UDI | Class I | Active |
| K-Reamers | N045 L25 | FDA UDI | Class I | Active |
| Evo Flex | N20 4% L21 Sterile | FDA UDI | Class I | Active |
| Square Broach | n20 L29 | FDA UDI | Class I | Active |
| K Files | n010 L25 | FDA UDI | Class I | Active |
| K-Files | N090 L31 | FDA UDI | Class I | Active |
| Rispi Sonic | n5 L19 | FDA UDI | Class I | Active |
| H-Files | N100 L31 | FDA UDI | Class I | Active |
| H-Files | N090 L31 | FDA UDI | Class I | Active |
| MicroMega One Curve mini | L31 Assorted Sterile | FDA UDI | Class I | Active |
| 2Shape | TS1 n25 4% L21 | FDA UDI | Class I | Active |
| Evo Flex | N20 4% L31 Sterile | FDA UDI | Class I | Active |
| K Files | n015 L25 | FDA UDI | Class I | Active |
| Revo-S | series L25 L21 | FDA UDI | Class I | Active |
| EdgeTaper Blaze Utopia | F3 L25 Sterile | FDA UDI | Class I | Active |
| H-Files | N070 L21 | FDA UDI | Class I | Active |
| K-Files | N030 L21 | FDA UDI | Class I | Active |
| Rispi Sonic | n0 L22 | FDA UDI | Class I | Active |
| K-Reamers | N030 L31 | FDA UDI | Class I | Active |
| H-Files | N035 L25 | FDA UDI | Class I | Active |
| H-Files | N090/140 L25 | FDA UDI | Class I | Active |
| MicroMega One Curve mini | n35 4% L31 Sterile | FDA UDI | Class I | Active |
| K-Files | N090/140 L31 | FDA UDI | Class I | Active |
| H-Files | N090 L25 | FDA UDI | Class I | Active |
| K-Reamers | N010 L25 | FDA UDI | Class I | Active |
| Spiral Fillers | n45 L21 | FDA UDI | Class I | Active |
| MicroMega REMOVER | L19 n30 7% | FDA UDI | Class I | Active |
| EdgeOne-R Utopia | Asst v2 L21 Sterile | FDA UDI | Class I | Active |
| Revo-S | AS30 L29 | FDA UDI | Class I | Active |
| K-Reamers | N008 L31 | FDA UDI | Class I | Active |
| Giro-Files | n015 L21 | FDA UDI | Class I | Active |
| 2Shape Mini | TS1 n25 4% L21 Classics | FDA UDI | Class I | Active |
| K-Reamers | N015/040 L31 | FDA UDI | Class I | Active |
| EdgeTaper Blaze Utopia | F3 L31 Sterile | FDA UDI | Class I | Active |
| 2Shape Mini | TS1 n25 4% L31 Classics sterile | FDA UDI | Class I | Active |
| K-Reamers | N045/080 L21 | FDA UDI | Class I | Active |
| MicroMega One Curve mini | n25 4% L25 Sterile | FDA UDI | Class I | Active |
| One Curve | n25 6% L31 | FDA UDI | Class I | Active |
| MicroMega REMOVER | L19 n30 7% | FDA UDI | Class I | Active |
| K-Files | N015/040 L25 | FDA UDI | Class I | Active |
| One Curve | n25 6% L25 | FDA UDI | Class I | Active |
| MicroMega One RECI Procedure Pack | N20 4% L25 Sterile | FDA UDI | Class I | Active |
| H-Files | N140 L31 | FDA UDI | Class I | Active |
| One Curve | n35 4% L21 | FDA UDI | Class I | Active |
| K-Files | N025 L25 | FDA UDI | Class I | Active |
| Giro-Files | n035 L25 | FDA UDI | Class I | Active |
| K-Files | N080 L21 | FDA UDI | Class I | Active |
| K-Reamers | N010 L31 | FDA UDI | Class I | Active |
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