Company ยท US
Henry Schein, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2004. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
5recalls (2 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EBF | Material, Tooth Shade, Resin | 2 |
| LYY | Latex Patient Examination Glove | 2 |
| DYN | Mouthpiece, Saliva Ejector | 1 |
| EAX | Mirror, Mouth | 1 |
| EEG | Heat Source For Bleaching Teeth | 1 |
| EFN | Cotton, Roll | 1 |
| EGZ | Holder, Film, X-Ray | 1 |
| EKC | Excavator, Dental, Operative | 1 |
| EMA | Cement, Dental | 1 |
| KOJ | Airbrush | 1 |
| MUH | System, X-Ray, Extraoral Source, Digital | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 29, 2004 | K041580 | IMAGERAYI Henry Schein, Inc. | MUH |
| Nov 7, 1986 | K862384 | SCHEIN AP-1 AIR POLISHING UNIT Henry Schein, Inc. | KOJ |
| Oct 30, 1986 | K862385 | SCHEIN BLEACHING UNIT Henry Schein, Inc. | EEG |
| Apr 25, 1984 | K841199 | FIBERGLASS MOUTH MIRRORS Henry Schein, Inc. | EAX |
| Feb 21, 1984 | K834055 | VANADIUM EXCAVATORS SIZES 0-6 Henry Schein, Inc. | EKC |
| Feb 3, 1984 | K834056 | SCHEIN COTTON ROLLS, NON-STERILE Henry Schein, Inc. | EFN |
| May 20, 1980 | K801079 | KWIX-BITE X-RAY FILM HOLDER Henry Schein, Inc. | EGZ |
| Dec 4, 1978 | K781592 | SURGICAL ASPIRATOR TIPS Henry Schein, Inc. | DYN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2026 | Henry Schein Inc. 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 25390 Open, Classified |
EBF | K051867 |
| Aug 25, 2026 | Henry Schein Inc. 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 Produc Open, Classified |
EBF | K040769 |
| Jan 11, 2012 | Henry Schein, Inc. Maxcem 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 ( Terminated |
EMA | K073209 |
| Jul 24, 2003 | Henry Schein, Inc. Positive 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, Terminated |
LYY | None listed |
| Jul 24, 2003 | Henry Schein, Inc. Positive 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 M Terminated |
LYY | None listed |