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Sign in to claim this brandHENRY SCHEIN, INC.
United States·US-MF-000021683
Last updated May 30, 2026
Information
- Country
- United States
- Address
- 135, Duryea Road, Melville, United States
- Website
- henryschein-dental.de
- —
- —
- [email protected]
- Phone
- +1(732)918-0770
- PRRC Contact
- Tracey Alexander
- EUDAMED SRN
- US-MF-000021683
- FDA FEI Number
- —
- DUNS Number
- 012430880
Catalogue (11454)
Page 3 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Henry Schein | 9007457 | FDA UDI | Class I | Active |
| Henry Schein | 9011493 | FDA UDI | Class II | Active |
| Henry Schein | 1067692 | FDA UDI | Class I | Active |
| Henry Schein | 9011480 | FDA UDI | Class II | Active |
| Henry Schein | 1126996 | FDA UDI | Class II | Active |
| Henry Schein | 1126229 | FDA UDI | Class II | Active |
| Henry Schein | 1125300 | FDA UDI | Class I | Active |
| Henry Schein | 5700190 | FDA UDI | Class I | Active |
| Maxi-Gard | 5702353 | FDA UDI | Class I | Active |
| Henry Schein | 5701207 | FDA UDI | Class I | Active |
| Maxima | 5702092 | FDA UDI | Class I | Active |
| Henry Schein | 5701371 | FDA UDI | Class I | Active |
| Henry Schein | 1125960 | FDA UDI | Class II | Active |
| Henry Schein | 9011810 | FDA UDI | Class II | Active |
| Henry Schein | 9011539 | FDA UDI | Class II | Active |
| Aloesoft Plus Nitrile PF | 1126406 | FDA UDI | Class I | Active |
| Henry Schein | 9009713 | FDA UDI | Class II | Active |
| Henry Schein | 5702881 | FDA UDI | Class II | Active |
| Criterion | 5703294 | FDA UDI | Class II | Active |
| Henry Schein | 9004868 | FDA UDI | Class I | Active |
| Henry Schein | 5702729 | FDA UDI | Class I | Active |
| Henry Schein | 9007526 | FDA UDI | Class I | Active |
| Henry Schein | 1127018 | FDA UDI | Class I | Active |
| Zirlux | 901-0913 | FDA UDI | Class II | Active |
| Henry Schein | 5702039 | FDA UDI | Class II | Active |
| Henry Schein | 9004777 | FDA UDI | Class I | Active |
| Henry Schein | 1125099 | FDA UDI | Class I | Active |
| Henry Schein | 1007601 | FDA UDI | Class I | Active |
| Z-Dent Anterior | 2285328 | FDA UDI | Class II | Active |
| Henry Schein | 5702807 | FDA UDI | Class II | Active |
| Henry Schein | 1008332 | FDA UDI | Class I | Active |
| Henry Schein | 1125931 | FDA UDI | Class II | Active |
| Henry Schein | 9007662 | FDA UDI | Class II | Active |
| Henry Schein | 1125220 | FDA UDI | Class I | Active |
| Henry Schein | 1061445 | FDA UDI | Class I | Active |
| Henry Schein | 1004502 | FDA UDI | Class I | Active |
| Henry Schein | 1125279 | FDA UDI | Class I | Active |
| Henry Schein | 1125878 | FDA UDI | Class II | Active |
| Henry Schein | 1016054 | FDA UDI | Class I | Active |
| Henry Schein | 1018228 | FDA UDI | Class I | Active |
| Henry Schein | 1127214 | FDA UDI | Class I | Active |
| Henry Schein | 1003220 | FDA UDI | Class I | Active |
| Henry Schein | 1008173 | FDA UDI | Class I | Active |
| Henry Schein | 9007088 | FDA UDI | Class I | Active |
| Henry Schein | 1000429 | FDA UDI | Class I | Active |
| Henry Schein | 5705549 | FDA UDI | Class I | Active |
| Henry Schein | 5702938 | FDA UDI | Class II | Active |
| Henry Schein | 8882627 | FDA UDI | Class II | Active |
| Henry Schein | 1134301 | FDA UDI | Class I | Active |
| Criterion Aloe Advance Latex | 1125840 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
Importers
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Authorities
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FDA Recalls (3)
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 |
|---|---|---|---|---|
| Nov 10, 2011 | Z-0390-2012 | — | terminated | The specific lots of Maxcem Elite Refill Kit appear not to be authentic. |
| Jun 27, 2003 | Z-1046-03 | — | terminated | FDA's analysis revealed defects (holes) in the latex gloves. |
| Jun 27, 2003 | Z-1045-03 | — | terminated | FDA's analysis revealed defects (holes) in the latex gloves. |