Data / Medical devices / Germany / Henry Schein Services GMBH
Henry Schein Services GMBH: FDA-registered device maker in Gallin Mecklenburg-Western Pomerania, Germany, 2 510(k) clearances
Henry Schein Services GMBH is registered with the FDA (registration 3009142030) in Gallin Mecklenburg-Western Pomerania, Germany. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 20, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009142030
- Address
- Am Heisterbusch 9, Gallin Mecklenburg-Western Pomerania, Germany, 19258
- Owner or operator
- HENRY SCHEIN, INC. (2411236)
- Roles
- Exporter to the US
- First device listed
- July 28, 1992
- Registered through
- 2026
- Brand names listed
- Contour Neck Bibs, Disposable Articulator Slotted, Fingertip Pulse Oximeter, Mirror Disposable Dental, SCISSORS, ORTHOPEDIC, SURGICAL, Smartlite Pro Sleeves Refill
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorber, Saliva, Paper | KHR | 1 | Exporter to the US | accessdata.fda.gov |
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Exporter to the US | accessdata.fda.gov |
| Articulators | EJP | 1 | Exporter to the US | accessdata.fda.gov |
| Light Transmission Caries Detector | NTK | 2 | Exporter to the US | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Exporter to the US | accessdata.fda.gov |
| Oximeter | DQA | 2 | Exporter to the US | accessdata.fda.gov |
| Scissors, Orthopedic, Surgical | HRR | 1 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 20, 2019 | K191865 | SmartLite Pro Modular LED Curing Light | EBZ | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| October 3, 2013 | K130947 | FINGERTIP PULSE OXIMETER | DQA | Substantially Equivalent | Beijing Choice Electronic Technololgy Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of Mirror, Mouth
- All makers of Activator, Ultraviolet, For Polymerization
- All makers of Light Transmission Caries Detector
- All makers of Absorber, Saliva, Paper
- All makers of Articulators
Updated November 20, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.