510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Henry Schein, Inc.

Indianapolis, IN, US

HENRY SCHEIN, INC. appears in FDA device records in Indianapolis, IN. FDA records list 8 510(k) clearances between and , no PMA records and 8 registered establishments. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
8
PMA records
0
Recall records
5
Registered establishments
8

510(k) clearance history

FDA records hold 8 510(k) clearances for Henry Schein, Inc. between 1978 and 2004. The busiest year on record is 1984, with 3. The most recent is 2004, with 1.

Clearances by year, as a table
510(k) clearance decisions for Henry Schein, Inc., by decision year
YearClearances
19781
19801
19843
19862
20041
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K041580IMAGERAYIMUHSubstantially Equivalent
K862384SCHEIN AP-1 AIR POLISHING UNITKOJSubstantially Equivalent
K862385SCHEIN BLEACHING UNITEEGSubstantially Equivalent
K841199FIBERGLASS MOUTH MIRRORSEAXSubstantially Equivalent
K834055VANADIUM EXCAVATORS SIZES 0-6EKCSubstantially Equivalent
K834056SCHEIN COTTON ROLLS, NON-STERILEEFNSubstantially Equivalent
K801079KWIX-BITE X-RAY FILM HOLDEREGZSubstantially Equivalent
K781592SURGICAL ASPIRATOR TIPSDYNSubstantially Equivalent

Registered establishments

FDA registered establishments for Henry Schein, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
18360161000549593HENRY SCHEIN, INC.5315 WEST 74TH ST., INDIANAPOLIS, IN 46268 US2026No device listings on this registration
24112361000143438HENRY SCHEIN, INC.41 WEAVER RD., DENVER, PA 17517 US2026No device listings on this registration
29547623003124891HENRY SCHEIN, INC.255 VISTA BLVD., SPARKS, NV 89434 US2026No device listings on this registration
30036491653003649165HENRY SCHEIN, INC.8691 JESSIE B. SMITH COURT, JACKSONVILLE, FL 32219 US2026No device listings on this registration
30121143843012114384HENRY SCHEIN, INC.5445 Guion Rd, Indianapolis, IN 46254 US2026No device listings on this registration
30297418333029741833Henry Schein, Inc.3701 Litsey Road, Fort Worth, TX 76177 US2026No device listings on this registration
30301314163030131416Henry Schein, Inc.180 Vista Blvd., Sparks, NV 89434 US2026No device listings on this registration
30436892033043689203Henry Schein, Inc.4925 Bulls Bay Hwy, Jacksonville, FL 32219 US2026No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-3016-2026Grandio 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.Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.Class IIOpen, Classified
Z-3015-2026Structur 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.Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.Class IIOpen, Classified
Z-0390-2012Maxcem Elite(TM) self-etch/self-adhesive resin cement, Refill Kit, net wt. 10 g, REF/Part # 33872, CLEAR --- Refill Kit Contents: 2 Syringes (5 g ea), 10 Automix tips (regular) 4:1, 10 Automix tips (wide) 4:1, 10 Intra-oral tips Dental resin cement. Self-etch, self-adhesive resin cement. High bond strength without adhesive needed. Easy to clean up and can be used with all anterior and posterior ceramics, PFMs, and CAD/CAM materials. Color stable and aesthetic. Works with all substrates from opaque to translucent.The specific lots of Maxcem Elite Refill Kit appear not to be authentic.Terminated
Z-1046-03Positive Touch (TM) SMOOTH POWDER-FREE LATEX EXAM GLOVES, LARGE. REORDER NO. 8878. Single Use Only. Qty. 100 Per Box (50 pairs), 1000 Per Case. Firm on label - Allegiance Healthcare Corporation, McGraw Park, IL 60085 USA (Allegiance a Cardinal Health company). Made in Malaysia.FDA's analysis revealed defects (holes) in the latex gloves.Terminated
Z-1045-03Positive Touch (TM) TEXTURED POWDER-FREE LATEX EXAM GLOVES, LARGE. REORDER NO. 8843. Single Use Only. Qty. 100 Per Box (50 pairs), 1000 Per Case. Firm on Label: Allegiance Healthcare Corporation McGraw Park, IL 60085 USA. Allegiance, a Cardinal Health company. Made in Malaysia.FDA's analysis revealed defects (holes) in the latex gloves.Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain