Oral-B Laboratories: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Oral-B Laboratories” (first 1988, latest 1995), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 94 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 |
|---|---|---|---|
| JES | Floss, Dental | 4 | 4 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| EFS | Unit, Oral Irrigation | 1 | 1 |
| JET | Pick, Massaging | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
Review panels
Most recent Oral-B Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943157 | ORAL-B ULTRAFLOSS WITH FLLUORIDE | JES | 1995-04-27 | 300 |
| K942633 | ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE | JET | 1995-04-27 | 328 |
| K943182 | ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR | EFS | 1994-09-09 | 70 |
| K932990 | ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP | EFB | 1993-09-29 | 103 |
| K925409 | ORAL-B DENTAL FLOSS WITH FLUORIDE | JES | 1993-01-28 | 94 |
| K925408 | ORAL-B DENTAL TAPE WITH FLUORIDE | JES | 1993-01-28 | 94 |
| K913603 | FIBRETWINS | KNT | 1991-09-30 | 47 |
| K883024 | ORAL-B FLOSSERS | JES | 1988-08-26 | 38 |
Recalls
openFDA lists no recalls under a recalling firm named Oral-B Laboratories.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Oral-B Laboratories?
FDA lists 8 510(k) clearances under the applicant name “Oral-B Laboratories” (first 1988, latest 1995), across 5 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 Oral-B Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oral-B Laboratories is 94 days.
Which FDA product codes appear under Oral-B Laboratories?
The most frequent FDA product codes under this applicant name are JES (Floss, Dental, 4); EFB (Handpiece, Air-Powered, Dental, 1); EFS (Unit, Oral Irrigation, 1).
Next steps
- See all 8 Oral-B Laboratories clearances with predicates and recalls
- Run predicate analysis for product code JES, Oral-B Laboratories'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.