HENRY SCHEIN SERVICES GMBH

FDA Device Registration & Listing · Gallin Mecklenburg-Western Pomerania, DE · Registration 3009142030

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009142030
FEI Number
3009142030
Entity Name
HENRY SCHEIN SERVICES GMBH
City/State/Country
Gallin Mecklenburg-Western Pomerania, DE
Establishment Address
Am Heisterbusch 9, Gallin Mecklenburg-Western Pomerania 19258, DE
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
HENRY SCHEIN, INC. (Owner Number: 2411236)
Owner / Operator Contact Address
135 DURYEA RD., --, Melville, NY 11747, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Mirror Disposable Dental Smartlite Pro Sleeves Refill Fingertip Pulse Oximeter Contour Neck Bibs

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EAX Mirror, Mouth Dental Class 1 872.4565 2025-07-16
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2025-02-27
NTK Caries Detector, Laser Light, Transmission Dental Class 2 872.1745 2025-02-27
DQA Oximeter Cardiovascular Class 2 870.2700 2025-02-27
KHR Absorber, Saliva, Paper Dental Class 1 872.6050 2025-07-16

Official Correspondent

Tracey Alexander

US Agent Details

Tracey Alexander Business: Henry Schein, Inc. Email: tracey.alexander@henryschein.com Phone: (631) 4543003

Related Public Records

Same Entity

HENRY SCHEIN, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243921 Foshan Coxo Medical Instrument Co., Ltd. LED Curing Lights (DB686 HALO) 2025-04-11
K033201 Apoza Enterprise Co., Ltd. LA500 BLUE LIGHT 2003-12-02
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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9615399 DIADENT GROUP INTL., INC. Vancouver British Columbia, CA
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009142030. Last updated year: 2026. Please use registration number 3009142030 when referencing this establishment in official correspondence.
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