Analytic Technology: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Analytic Technology” (first 1979, latest 1992), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 82 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 |
|---|---|---|---|
| EAT | Tester, Pulp | 2 | 2 |
| EKM | Gutta-Percha | 2 | 2 |
| LQY | Locator, Root Apex | 2 | 2 |
| EEG | Heat Source For Bleaching Teeth | 1 | 1 |
| EKZ | Unit, Electrosurgical, And Accessories, Dental | 1 | 1 |
| ELA | Instrument, Hand, Calculus Removal | 1 | 1 |
Review panels
- Dental (9)
Most recent Analytic Technology 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921604 | TOUCH N' HEAT, MODIFICATION | EKZ | 1992-08-24 | 150 |
| K915243 | TOUCH 'N HEAT MODEL 5002, MODIFICATION | EKM | 1992-01-21 | 82 |
| K890735 | COATED APEX PROBE | LQY | 1989-04-19 | 65 |
| K864500 | ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001 | LQY | 1987-03-19 | 125 |
| K832179 | HOT PROBE MODEL 6001 | EEG | 1983-10-04 | 90 |
| K823486 | TOUCH-N-HEAT MODEL 5001 | EKM | 1983-01-18 | 56 |
| K820598 | HOT & COLD PULP TESTER #4001 | EAT | 1982-03-19 | 15 |
| K801974 | ANALYTIC TECH. METAL POINT HEATER #3001 | ELA | 1980-11-12 | 85 |
| K790799 | PULPTESTER MODEL 2001 | EAT | 1979-05-31 | 37 |
Recalls
openFDA lists no recalls under a recalling firm named Analytic Technology.
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 Analytic Technology?
FDA lists 9 510(k) clearances under the applicant name “Analytic Technology” (first 1979, latest 1992), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Analytic Technology?
The median time from FDA receipt to decision across 510(k)s cleared under the name Analytic Technology is 82 days.
Which FDA product codes appear under Analytic Technology?
The most frequent FDA product codes under this applicant name are EAT (Tester, Pulp, 2); EKM (Gutta-Percha, 2); LQY (Locator, Root Apex, 2).
Next steps
- See all 9 Analytic Technology clearances with predicates and recalls
- Run predicate analysis for product code EAT, Analytic Technology'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.