Air Techniques, Inc.: FDA clearances and approvals
Air Techniques, Inc. has 18 FDA 510(k) clearances (first 1995, latest 2019), across 11 product codes in 2 review panels. Median 510(k) review time: 88 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 | 2 | 85 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Air Techniques, Inc.'s cleared 510(k)s took a median 85 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 66 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EIA | Unit, Operative Dental | 4 | 4 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 3 | 3 |
| MUH | System, X-Ray, Extraoral Source, Digital | 3 | 3 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| ELC | Scaler, Ultrasonic | 1 | 1 |
| KOJ | Airbrush | 1 | 1 |
| NBL | Light-Induced Fluorescence Caries Detector | 1 | 1 |
| NRD | Unit, Operative Dental, Accessories | 1 | 1 |
| NYL | Handpiece, Air-Powered, Root Canal Irrigation | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Air Techniques, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191623 | ScanX Touch/ScanX Duo Touch | MUH | 2019-08-21 | 64 |
| K190949 | ScanX Barrier Envelopes | PEM | 2019-07-26 | 106 |
| K101289 | SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB | MQB | 2010-08-03 | 88 |
| K090169 | SPECTRA FLUORESCENCE CARIES DETECTION DEVICE | NBL | 2009-08-18 | 207 |
| K052271 | RINSENDO | NYL | 2006-05-26 | 280 |
| K050693 | ACCENT | MUH | 2005-05-26 | 70 |
| K042397 | SCANX 14 | MQB | 2004-10-05 | 33 |
| K042266 | ACCLAIM | NRD | 2004-08-31 | 8 |
| K031198 | SCANX 10 | MQB | 2003-06-20 | 65 |
| K024285 | A/T X-RAY 70 | EHD | 2003-04-16 | 114 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Air Techniques, Inc..
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 Air Techniques, Inc. have?
Air Techniques, Inc. has 18 FDA 510(k) clearances (first 1995, latest 2019), across 11 product codes in 2 review panels.
How long does FDA take to clear Air Techniques, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Air Techniques, Inc.'s cleared 510(k)s is 88 days.
What devices does Air Techniques, Inc. make?
Its most frequent FDA product codes are EIA (Unit, Operative Dental, 4); MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 3); MUH (System, X-Ray, Extraoral Source, Digital, 3).
Has Air Techniques, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Air Techniques, Inc. Related entities may recall under other names.
Next steps
- See all 18 Air Techniques, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EIA, Air Techniques, Inc.'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.