Henry Schein, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Henry Schein, Inc.” (first 1978, latest 2004), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 74 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYN | Mouthpiece, Saliva Ejector | 1 | 1 |
| EAX | Mirror, Mouth | 1 | 1 |
| EEG | Heat Source For Bleaching Teeth | 1 | 1 |
| EFN | Cotton, Roll | 1 | 1 |
| EGZ | Holder, Film, X-Ray | 1 | 1 |
| EKC | Excavator, Dental, Operative | 1 | 1 |
| KOJ | Airbrush | 1 | 1 |
| MUH | System, X-Ray, Extraoral Source, Digital | 1 | 1 |
Review panels
Most recent Henry Schein, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041580 | IMAGERAYI | MUH | 2004-06-29 | 15 |
| K862384 | SCHEIN AP-1 AIR POLISHING UNIT | KOJ | 1986-11-07 | 136 |
| K862385 | SCHEIN BLEACHING UNIT | EEG | 1986-10-30 | 128 |
| K841199 | FIBERGLASS MOUTH MIRRORS | EAX | 1984-04-25 | 35 |
| K834055 | VANADIUM EXCAVATORS SIZES 0-6 | EKC | 1984-02-21 | 90 |
| K834056 | SCHEIN COTTON ROLLS, NON-STERILE | EFN | 1984-02-03 | 72 |
| K801079 | KWIX-BITE X-RAY FILM HOLDER | EGZ | 1980-05-20 | 13 |
| K781592 | SURGICAL ASPIRATOR TIPS | DYN | 1978-12-04 | 77 |
Recalls
5 product recalls in 3 recall events; 2 initiated in the last five years. Most recent: 2026-07-09.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
HENRY SCHEIN INC (HSIC): EDGAR filings, CIK 1000228. An SEC registrant with the same name, matched by name only.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Henry Enterprises, Inc. (1 510(k)s)
- Henry Ford Hospital (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Henry Schein, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Henry Schein, Inc.” (first 1978, latest 2004), across 8 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Henry Schein, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Henry Schein, Inc. is 74 days.
Which FDA product codes appear under Henry Schein, Inc.?
The most frequent FDA product codes under this applicant name are DYN (Mouthpiece, Saliva Ejector, 1); EAX (Mirror, Mouth, 1); EEG (Heat Source For Bleaching Teeth, 1).
Next steps
- See all 8 Henry Schein, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYN, Henry Schein, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.