Aseptico, Inc.: FDA clearances and approvals
Aseptico, Inc. has 18 FDA 510(k) clearances (first 1988, latest 2015), across 6 product codes in 1 review panel. Median 510(k) review time: 104 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 153 |
| 2014 | 1 | 149 |
| 2015 | 1 | 127 |
| 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | 5 | 5 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 5 | 5 |
| EIE | Dam, Rubber | 3 | 3 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 2 | 2 |
| ELC | Scaler, Ultrasonic | 2 | 2 |
| LQY | Locator, Root Apex | 1 | 1 |
Review panels
- Dental (18)
Most recent Aseptico, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150129 | AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) | EKX | 2015-05-28 | 127 |
| K142124 | AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM | EKX | 2014-12-31 | 149 |
| K130693 | AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM | ELC | 2013-08-14 | 153 |
| K111078 | AEU-26L ELCTRONIC ENDODONTIC SYSTEM | EKX | 2011-06-14 | 57 |
| K101332 | AMC-20 PORTABLE DENTAL CART MODEL AMC-20 | EIA | 2011-04-11 | 334 |
| K103399 | GENERAL DENISTRY MOTOR | EKX | 2011-02-28 | 101 |
| K070866 | ASC-12 PIEZOELECTRIC SCALER | ELC | 2007-04-11 | 13 |
| K051077 | E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 | EGS | 2005-05-03 | 6 |
| K050201 | AEU-14CF EXPENDITION | EIA | 2005-03-18 | 49 |
| K030895 | ASEPTICO ENDOPEX V, MODEL AEU-40 | LQY | 2003-12-03 | 257 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Aseptico, 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 Aseptico, Inc. have?
Aseptico, Inc. has 18 FDA 510(k) clearances (first 1988, latest 2015), across 6 product codes in 1 review panel.
How long does FDA take to clear Aseptico, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Aseptico, Inc.'s cleared 510(k)s is 104 days.
What devices does Aseptico, Inc. make?
Its most frequent FDA product codes are EIA (Unit, Operative Dental, 5); EKX (Handpiece, Direct Drive, Ac-Powered, 5); EIE (Dam, Rubber, 3).
Has Aseptico, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Aseptico, Inc. Related entities may recall under other names.
Next steps
- See all 18 Aseptico, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EIA, Aseptico, 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.