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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 24 Abeel Rd, Monroe, NJ, 08831
- Website
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- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3027344570
- DUNS Number
- —
Catalogue (326)
Page 7 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ProShape C Files Size 25 25mm | CF2525 | FDA UDI | Class I | Active |
| ProShape Paper Points ISO 35.04 | PSPP3504 | FDA UDI | Class I | Active |
| ProShape Retreat; Asst 22 mm | PSRT31 | FDA UDI | Class I | Active |
| ProShape Gutta Percha ISO 35.06 | SDPP4506 | FDA UDI | Class I | Unknown |
| ProShape Conserve 06 Size 40 25MM | PSC400625 | FDA UDI | Class I | Active |
| ProShape Paper Points ISO 40.06 | PSOPPPR | FDA UDI | Class I | Unknown |
| ProShape Conserve 06 Size 35 31MM | PSC350631 | FDA UDI | Class I | Active |
| ProShape Cyclone 04 Size 25 21MM | PS250421 | FDA UDI | Class I | Active |
| ProShape Gutta Percha F4 | PSGPF4 | FDA UDI | Class I | Active |
| ProShape One Gutta Percha Large | SDGP40061 | FDA UDI | Class I | Unknown |
| ProShape Retreat; Asst 16 mm | PSRT21 | FDA UDI | Class I | Active |
| ProShape Cyclone 04 Size 45 25MM | PS450425 | FDA UDI | Class I | Active |
| ProShape Paper Points ISO 45.06 | PSPP4506 | FDA UDI | Class I | Active |
| ProShape HT S2 6 pack; 31 mm | PSHTS231 | FDA UDI | Class I | Active |
| ProShape C Files Size 6 25mm | CF0625 | FDA UDI | Class I | Active |
| ProShape Conserve 04 Size 70 21MM | PSC700421 | FDA UDI | Class I | Active |
| ProShape HT F4 6 pack; 31 mm | PSHTF431 | FDA UDI | Class I | Active |
| ProShape One Paper Points Primary | PSOPPPR | FDA UDI | Class I | Active |
| ProShape Gutta Percha ISO 20.06 | SDPP3006 | FDA UDI | Class I | Unknown |
| ProShape C Files Size 8 21mm | CF0821 | FDA UDI | Class I | Active |
| ProShape Gutta Percha ISO 60.04 | PSGP6004 | FDA UDI | Class I | Active |
| ProShape Cyclone 04 Size 40 25MM | PS400425 | FDA UDI | Class I | Active |
| ProShape Gutta Percha ISO 45.06 | PSGPF1 | FDA UDI | Class I | Unknown |
| ProShape Paper Points ISO 50.04 | PSPP5004 | FDA UDI | Class I | Active |
| ProShape SX 6 pack; 19 mm | PSSX19 | FDA UDI | Class I | Active |
| ProShape Conserve 04 Size 30 31MM | PSC300431 | FDA UDI | Class I | Active |
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