Henry Schein Inc.
FDA Regulatory Profile
Henry Schein Inc. appears in FDA public data with 2 recalls, 8 510(k) clearances, 8 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-3016-2026, Class II) was initiated on July 9, 2026. Its most recent 510(k) clearance was granted on June 29, 2004.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 8
- Inspections
- 8
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3016-2026 | Class II | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, | July 9, 2026 |
| Z-3015-2026 | Class II | Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code | July 9, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K041580 | IMAGERAYI | June 29, 2004 |
| K862384 | SCHEIN AP-1 AIR POLISHING UNIT | November 7, 1986 |
| K862385 | SCHEIN BLEACHING UNIT | October 30, 1986 |
| K841199 | FIBERGLASS MOUTH MIRRORS | April 25, 1984 |
| K834055 | VANADIUM EXCAVATORS SIZES 0-6 | February 21, 1984 |
| K834056 | SCHEIN COTTON ROLLS, NON-STERILE | February 3, 1984 |
| K801079 | KWIX-BITE X-RAY FILM HOLDER | May 20, 1980 |
| K781592 | SURGICAL ASPIRATOR TIPS | December 4, 1978 |