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HENRY SCHEIN, INC.

United States·US-MF-000021683

Last updated May 30, 2026

Information

Country
United States
Address
135, Duryea Road, Melville, United States
LinkedIn
—
Facebook
—
Phone
+1(732)918-0770
PRRC Contact
Tracey Alexander
EUDAMED SRN
US-MF-000021683
FDA FEI Number
—
DUNS Number
012430880

Catalogue (11454)

Page 12 of 230
DeviceModel / ReferenceRegistriesClassStatus
Henry Schein 1001366
FDA UDI
Class IActive
Henry Schein 5701654
FDA UDI
Class IIActive
Henry Schein 9007419
FDA UDI
Class IActive
Henry Schein 9012170
FDA UDI
Class IIActive
Henry Schein 5702839
FDA UDI
Class IIActive
Henry Schein 2020357
FDA UDI
Class IActive
Henry Schein 5701610
FDA UDI
Class IIActive
Henry Schein 5700774
FDA UDI
Class IActive
Henry Schein 9007427
FDA UDI
Class IActive
Henry Schein 9011816
FDA UDI
Class IIActive
Henry Schein 9011538
FDA UDI
Class IIActive
Maxima Posterior 2283533
FDA UDI
Class IIActive
Henry Schein 9007108
FDA UDI
Class IActive
Henry Schein 1013025
FDA UDI
Class IActive
Henry Schein 9011127
FDA UDI
Class IIActive
Henry Schein 5701470
FDA UDI
Class IActive
Henry Schein 5700011
FDA UDI
Class IActive
Reveal™ Aligners 1359817
FDA UDI
Class IIActive
Henry Schein 1001563
FDA UDI
Class IActive
Henry Schein 9011118
FDA UDI
Class IIActive
Henry Schein 5750020
FDA UDI
Class IIActive
Henry Schein 5700769
FDA UDI
Class IActive
Maxima 5702083
FDA UDI
Class IActive
Henry Schein 9011447
FDA UDI
Class IIActive
Henry Schein 1009374
FDA UDI
Class IActive
Essentials 1126750
FDA UDI
Class IIActive
Henry Schein 1004601
FDA UDI
Class IActive
Henry Schein 8882629
FDA UDI
Class IIActive
Criterion 5703461
FDA UDI
Class IActive
Henry Schein 1126302
FDA UDI
Class IActive
Maxi-Gard 5702338
FDA UDI
Class IActive
Henry Schein Acclean 5703748
FDA UDI
Class IActive
Henry Schein 5701496
FDA UDI
Class IIActive
Henry Schein 5702401
FDA UDI
Class IActive
Henry Schein 5701619
FDA UDI
Class IIActive
Henry Schein 1046350
FDA UDI
Class IActive
Hseu 5702546
FDA UDI
UActive
Reveal™ Aligners 1359803
FDA UDI
Class IIActive
Henry Schein 9007154
FDA UDI
Class IActive
Henry Schein 9007425
FDA UDI
Class IActive
Henry Schein 1125199
FDA UDI
Class IActive
Nytrile X300 Electra Blue PF Nitrile 1127017
FDA UDI
Class IActive
Henry Schein 5700999
FDA UDI
Class IActive
Henry Schein Acclean 5703791
FDA UDI
Class IActive
Henry Schein 9004770
FDA UDI
Class IActive
Henry Schein 2020311
FDA UDI
Class IActive
Essentials 5700571
FDA UDI
Class IIActive
Henry Schein 1000096
FDA UDI
Class IActive
Henry Schein 5703875
FDA UDI
Class IIActive
Henry Schein 1125444
FDA UDI
Class IActive

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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.

DateRecall No.ClassStatusReason
Nov 10, 2011Z-0390-2012—terminated

The specific lots of Maxcem Elite Refill Kit appear not to be authentic.

Jun 27, 2003Z-1046-03—terminated

FDA's analysis revealed defects (holes) in the latex gloves.

Jun 27, 2003Z-1045-03—terminated

FDA's analysis revealed defects (holes) in the latex gloves.