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Sign in to claim this brandHENRY SCHEIN, INC.
United States·US-MF-000021683
Last updated May 30, 2026
What HENRY SCHEIN, INC. makes
Henry Schein, Inc. manufactures single-use general surgical procedure kits, reusable dental burs (diamond and carbide), manual endodontic files/rasps, ceramic dental appliance fabrication materials, synthetic gutta-percha, and one-piece screw endosteal dental implants. The company also produces nitrile examination/treatment gloves that are non-powdered and non-antimicrobial.
The portfolio includes devices classified as Class I, Class II, Class IIa, and Unclassified (U), with listings in the EU’s eudamed registry and the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Henry Schein, Inc. manufacture?
Henry Schein, Inc. produces a range of medical devices primarily for surgical and dental applications. These include single-use general surgical procedure kits, reusable dental tools like diamond and carbide burs, manual endodontic files/rasps, ceramic materials for dental appliance fabrication, synthetic gutta-percha for root canal treatments, and one-piece screw endosteal dental implants. The company also manufactures nitrile examination gloves that are non-powdered and non-antimicrobial.
Where is Henry Schein, Inc. based, and what is its primary focus?
Henry Schein, Inc. is based in the United States. Its primary focus is on manufacturing medical devices for surgical and dental professionals, covering both single-use and reusable products. The company’s portfolio spans general surgical tools, dental instruments, and materials, catering to specific clinical needs in these fields.
Which regulatory registries list Henry Schein, Inc.’s devices?
Henry Schein, Inc.’s devices are listed in two key regulatory registries: the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) database. These registries track device information for compliance and transparency in their respective markets, ensuring authorized devices are identifiable and traceable.
How are Henry Schein, Inc.’s devices classified under regulatory frameworks?
Henry Schein, Inc.’s devices fall into multiple regulatory classifications, including Class I, Class II, Class IIa, and Unclassified (U). The classification depends on factors like risk level, intended use, and potential impact on patient safety. For example, single-use surgical kits may qualify as Class I due to low risk, while dental implants or endodontic tools could fall into higher-risk categories like Class II or IIa.
Why might some of Henry Schein’s devices appear in both eudamed and FDA UDI databases?
Henry Schein’s devices appear in both registries because the company operates in markets governed by the European Union (EU) and the United States (US), each with its own regulatory requirements. The EU’s eudamed is mandatory for devices placed on the market within the EU, while the FDA’s UDI database is required for devices sold in the US. Listing in both ensures compliance with regional regulations and facilitates global traceability for authorized products.
AI-generated from registry data and not verified by a human reviewer.
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 224 of 230| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Maxi-Gard | 5702279 | FDA UDI | Class I | Active |
| Channels | 2020519 | FDA UDI | Class I | Active |
| Channels | 2020624 | FDA UDI | Class I | Active |
| Maxi-Gard | 5702317 | FDA UDI | Class I | Active |
| Criterion | 5704497 | FDA UDI | Class I | Active |
| Zirlux | 9010753 | FDA UDI | Class II | Active |
| Zirlux | 901-0945 | FDA UDI | Class II | Active |
| Criterion Glove PF Nitrile LF | 1118539 | FDA UDI | Class I | Active |
| Criterion PC Glove PF Latex | 1025422 | FDA UDI | Class I | Active |
| Reveal™ Aligners | 1359852 | FDA UDI | Class II | Active |
| Zirlux | 9012362 | FDA UDI | Class II | Active |
| Criterion | 5702100 | FDA UDI | Class I | Active |
| Criterion | 5703462 | FDA UDI | Class I | Active |
| Channels | 2020135 | FDA UDI | Class I | Active |
| Zirlux | 901-0407 | FDA UDI | Class II | Active |
| Nytrile X200 PF Nitrile | 1125661 | FDA UDI | Class I | Active |
| Channels | 2020541 | FDA UDI | Class I | Active |
| Illusion Glove PF Latex Grape | 1032712 | FDA UDI | Class I | Active |
| Criterion Chloroprene 3.8G | 5702438 | FDA UDI | Class I | Active |
| Zirlux | 9012633 | FDA UDI | Class II | Active |
| Channels | 2020127 | FDA UDI | Class I | Active |
| Reveal™ Aligners | 1359826 | FDA UDI | Class II | Active |
| Zirlux | 9012323 | FDA UDI | Class II | Active |
| ZCAD TempFix | 9007924 | FDA UDI | Class I | Active |
| Zirlux | 9012217 | FDA UDI | Class II | Active |
| Criterion Glove PF Nitrile LF | 1118537 | FDA UDI | Class I | Active |
| Illusion Glove PF Latex Grape | 1032700 | FDA UDI | Class I | Active |
| Zirlux | 9010314 | FDA UDI | Class II | Active |
| Zirlux | 9012230 | FDA UDI | Class II | Active |
| Ionosphere | 1008182 | FDA UDI | Class II | Active |
| Zirlux | 9010590 | FDA UDI | Class I | Active |
| Endoflex | 5701938 | FDA UDI | Class I | Active |
| Criterion CR Surgeons Glove | 1127088 | FDA UDI | Class I | Active |
| Carina | 570-3123 | FDA UDI | Class I | Active |
| Zirlux | 9012216 | FDA UDI | Class II | Active |
| Stratosphere | 1002362 | FDA UDI | Class II | Active |
| Maxizyme Tablets | 9000475 | FDA UDI | Class I | Active |
| Reveal™ Aligners | 1359813 | FDA UDI | Class II | Active |
| Image Tooth Shade Acrylic | 2282581 | FDA UDI | Class II | Active |
| Illusion Glove PF Bubble Gum | 1044062 | FDA UDI | Class I | Active |
| Zirlux | 9012210 | FDA UDI | Class II | Active |
| Channels | 2020582 | FDA UDI | Class I | Active |
| Cyber-Gel Glove PF Latex | 1035133 | FDA UDI | Class I | Active |
| Essentials PF Nitrile Glove | 1126765 | FDA UDI | Class I | Active |
| Maxi-Gard | 5702287 | FDA UDI | Class I | Active |
| Henry Schein Maxima | 5720875 | EUDAMEDFDA UDI | Class I | Active |
| Henry Schein Maxima | 9008526 | EUDAMED | Class I | Active |
| Henry Schein Maxima | 9002168 | EUDAMED | Class I | Active |
| Henry Schein Maxima | 9000755 | EUDAMED | Class I | Active |
| Vanadium Excavators Sizes 0-6 | K834055 | FDA 510(k) | Class I | Active |
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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.
Henry Schein, Inc. has three recall records initiated between June 27, 2003, and November 10, 2011, all of which are marked as terminated. The reasons cited include defects—specifically holes—in latex gloves identified by FDA analysis and concerns over the authenticity of specific lots of the Maxcem Elite Refill Kit.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| 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. |