Teledyne Getz: FDA clearances and approvals
Teledyne Getz has 5 FDA 510(k) clearances (first 1990, latest 1992), across 4 product codes in 2 review panels. Median 510(k) review time: 78 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 |
|---|---|---|---|
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 2 | 2 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| KOB | Catheter, Suprapubic (And Accessories) | 1 | 1 |
| KOT | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium | 1 | 1 |
Review panels
Most recent Teledyne Getz 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923675 | DENSPRO MEDIUM MINT PROPHY PASTE | EJR | 1992-11-05 | 106 |
| K923674 | DENSPRO COARSE MINT PROPHY PASTE | EJR | 1992-11-05 | 106 |
| K903568 | SUPER STRENGTH DENTURE ADHESIVE CREAM | KOT | 1990-10-24 | 78 |
| K901938 | SUPER STRENGTH DENTURE ADHESIVE CREAM | KOB | 1990-06-06 | 37 |
| K901239 | TELEDYNE GETZ'S DISPOSABLE PROPHY ANGLE | EFB | 1990-05-15 | 61 |
Recalls
openFDA lists no recalls under a recalling firm named Teledyne Getz.
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 Teledyne Getz have?
Teledyne Getz has 5 FDA 510(k) clearances (first 1990, latest 1992), across 4 product codes in 2 review panels.
How long does FDA take to clear Teledyne Getz's 510(k)s?
The median time from FDA receipt to decision across Teledyne Getz's cleared 510(k)s is 78 days.
What devices does Teledyne Getz make?
Its most frequent FDA product codes are EJR (Agent, Polishing, Abrasive, Oral Cavity, 2); EFB (Handpiece, Air-Powered, Dental, 1); KOB (Catheter, Suprapubic (And Accessories), 1).
Has Teledyne Getz had device recalls?
openFDA lists no recalls under a recalling firm name matching Teledyne Getz. Related entities may recall under other names.
Next steps
- See all 5 Teledyne Getz clearances with predicates and recalls
- Run predicate analysis for product code EJR, Teledyne Getz'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.