Sybron Dental Specialties, Inc.: FDA filings under this applicant name
FDA lists 121 510(k) clearances under the applicant name “Sybron Dental Specialties, Inc.” (first 1994, latest 2018), across 28 product codes in 2 review panels. Median 510(k) review time under this name: 65 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Envista (Nobel Biocare, Ormco, Kerr), based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 62 |
| 2014 | 0 | — |
| 2015 | 4 | 92 |
| 2016 | 4 | 206 |
| 2017 | 1 | 269 |
| 2018 | 1 | 6 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sybron Dental Specialties, Inc. took a median 138 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 141 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 28 | 28 |
| EMA | Cement, Dental | 14 | 14 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 12 | 12 |
| ELW | Material, Impression | 10 | 10 |
| KLE | Agent, Tooth Bonding, Resin | 9 | 9 |
| EBG | Crown And Bridge, Temporary, Resin | 6 | 6 |
| KIF | Resin, Root Canal Filling | 6 | 6 |
| EJK | Liner, Cavity, Calcium Hydroxide | 5 | 5 |
| EAT | Tester, Pulp | 4 | 4 |
| DYW | Bracket, Plastic, Orthodontic | 3 | 3 |
Plus 18 more product codes.
Review panels
- Dental (120)
- General Hospital (1)
Most recent Sybron Dental Specialties, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182826 | Ormco Spark Aligner System | NXC | 2018-10-11 | 6 |
| K162063 | Steri-Cassette and Steri-Cage Sterilization Packaging System | KCT | 2017-04-21 | 269 |
| K160097 | Image Fast Set, Image Regular Set | ELW | 2016-08-05 | 199 |
| K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress | KIF | 2016-07-27 | 279 |
| K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWT | KIF | 2016-05-06 | 212 |
| K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes | KIF | 2016-04-14 | 190 |
| K151526 | Zone, ZoneFree, Zone A1 | EMA | 2015-09-10 | 94 |
| K151332 | Nexus Universal, Nexus Universal Chroma | EMA | 2015-08-17 | 90 |
| K150559 | Life Fast Set, Life Regular Set | EJK | 2015-06-19 | 105 |
| K143209 | SonicFill 2 | EBF | 2015-02-05 | 87 |
111 earlier clearances. See the full list in Caduvo.
Recalls
21 product recalls in 10 recall events; 0 initiated in the last five years. Most recent: 2015-02-11.
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.
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.
- Sybron Corp. (37 510(k)s)
- Sybron Endo/Analytic (3 510(k)s)
- Sybron Endo (1 510(k)s)
- Sybron Implant Solutions GmbH (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sybron Dental Specialties, Inc.?
FDA lists 121 510(k) clearances under the applicant name “Sybron Dental Specialties, Inc.” (first 1994, latest 2018), across 28 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 Sybron Dental Specialties, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sybron Dental Specialties, Inc. is 65 days.
Which FDA product codes appear under Sybron Dental Specialties, Inc.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 28); EMA (Cement, Dental, 14); DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 12).
Next steps
- See all 121 Sybron Dental Specialties, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Sybron Dental Specialties, 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.