Sybron Corp.: FDA clearances and approvals
Sybron Corp. has 37 FDA 510(k) clearances (first 1977, latest 1986), across 28 product codes in 7 review panels. Median 510(k) review time: 33 days.
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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| ELW | Material, Impression | 2 | 2 |
| EMA | Cement, Dental | 2 | 2 |
| FRC | Indicator, Biological Sterilization Process | 2 | 2 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
| DZN | Instruments, Dental Hand | 1 | 1 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EBD | Coating, Filling Material, Resin | 1 | 1 |
Plus 18 more product codes.
Review panels
- Dental (12)
- General Hospital (9)
- General and Plastic Surgery (7)
- Radiology (3)
- Cardiovascular (2)
- Gastroenterology and Urology (1)
- Microbiology (1)
Most recent Sybron Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K862284 | SEALITE | EBC | 1986-06-23 | 7 |
| K854855 | PROOF ALGINATE IMPRESSION MATERIAL | ELW | 1986-01-30 | 56 |
| K844092 | DIAGNOSTIC MICROSOPCE SLIDES | — | 1984-10-25 | 6 |
| K842132 | TYCOS SELF-CHECK/DIGITAL FEVER THERMO | FLL | 1984-07-18 | 49 |
| K841910 | KERR SEALAPEX ROOT CANAL SEALER | EJK | 1984-07-13 | 65 |
| K841732 | LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM | IZP | 1984-06-05 | 40 |
| K840469 | TYCOS SELF CHECK BPM3 BLOOD PRESS MONI | DXN | 1984-05-21 | 108 |
| K840407 | KERR RESIN BONDED BRIDGE CEMENT | EMA | 1984-05-21 | 111 |
| K840607 | LF MOTORIZED RADIOGRAPHIC FILM VIEWER | IXC | 1984-03-05 | 21 |
| K833138 | DIGITAL INJECTOR SYS | DXT | 1983-11-14 | 61 |
27 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sybron Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Sybron Corp. have?
Sybron Corp. has 37 FDA 510(k) clearances (first 1977, latest 1986), across 28 product codes in 7 review panels.
How long does FDA take to clear Sybron Corp.'s 510(k)s?
The median time from FDA receipt to decision across Sybron Corp.'s cleared 510(k)s is 33 days.
What devices does Sybron Corp. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2); EBF (Material, Tooth Shade, Resin, 2).
Has Sybron Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sybron Corp. Related entities may recall under other names.
Next steps
- See all 37 Sybron Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Sybron Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.