Henry Schein, Inc.

Henry Schein, Inc. holds 8 FDA 510(k) medical device clearances, first cleared 1978, most recent 2004, with 2 FDA device recalls on record.

FDA recalls by Henry Schein, Inc.

Z-3015-2026 — Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code 1479; Lots 2536179, 2606429 2) 114-3934, Mfr Product Code 1480; Lot 2539064 3) 114-3935, Mfr Product Code 1481; Lot 2533123 4) 114-3937, Mfr Product Code 1482; Lots 2533203, 2607170 is a fluorescent cold polymerizing paste-paste system for the production of temporary crowns, bridges, inlays and onlays.Class II·Ongoing·2026-07-09
Z-3016-2026 — Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product Code 1840; Lots 2529604, 2538147, 2608145 2) 949-3595, Mfr Product Code 1841; Lots 2539075, 2539313, 2609789, 2539065 3) 949-3596, Mfr Product Code 1842; Lots 2536632, 2609174, 2610099 4) 949-3597, Mfr Product Code 1843; Lots 2535296, 2537418, 2607283 is a light-cured, nano-hybrid dental composite restorative material intended for direct restorative procedures.Class II·Ongoing·2026-07-09

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

Recent clearances by Henry Schein, Inc.

K041580 — IMAGERAYICode MUH·2004-06-29
K862384 — SCHEIN AP-1 AIR POLISHING UNITCode KOJ·1986-11-07
K862385 — SCHEIN BLEACHING UNITCode EEG·1986-10-30
K841199 — FIBERGLASS MOUTH MIRRORSCode EAX·1984-04-25
K834055 — VANADIUM EXCAVATORS SIZES 0-6Code EKC·1984-02-21
K834056 — SCHEIN COTTON ROLLS, NON-STERILECode EFN·1984-02-03
K801079 — KWIX-BITE X-RAY FILM HOLDERCode EGZ·1980-05-20
K781592 — SURGICAL ASPIRATOR TIPSCode DYN·1978-12-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.

Top product codes for Henry Schein, Inc.

FDA recalls by Henry Schein, Inc.

Recent clearances by Henry Schein, Inc.