Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aseptico, Inc. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
334 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150129 | AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERS | Aseptico, Inc. | 2015-05-28 | 127 | 0 |
| K142124 | AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM | Aseptico, Inc. | 2014-12-31 | 149 | 0 |
| K130693 | AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM | Aseptico, Inc. | 2013-08-14 | 153 | 0 |
| K111078 | AEU-26L ELCTRONIC ENDODONTIC SYSTEM | Aseptico, Inc. | 2011-06-14 | 57 | 0 |
| K101332 | AMC-20 PORTABLE DENTAL CART MODEL AMC-20 | Aseptico, Inc. | 2011-04-11 | 334 | 0 |
| K103399 | GENERAL DENISTRY MOTOR | Aseptico, Inc. | 2011-02-28 | 101 | 0 |
| K070866 | ASC-12 PIEZOELECTRIC SCALER | Aseptico, Inc. | 2007-04-11 | 13 | 0 |
| K051077 | E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 | Aseptico, Inc. | 2005-05-03 | 6 | 0 |
| K050201 | AEU-14CF EXPENDITION | Aseptico, Inc. | 2005-03-18 | 49 | 0 |
| K030895 | ASEPTICO ENDOPEX V, MODEL AEU-40 | Aseptico, Inc. | 2003-12-03 | 257 | 0 |
| K030163 | ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 | Aseptico, Inc. | 2003-03-03 | 46 | 0 |
| K022217 | AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM | Aseptico, Inc. | 2002-10-24 | 108 | 0 |
| K020137 | AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRA | Aseptico, Inc. | 2002-03-04 | 47 | 0 |
| K923157 | DENTAL RUBBER DAM | Aseptico, Inc. | 1993-07-22 | 388 | 0 |
| K923163 | RUBBER DAM CLAMP | Aseptico, Inc. | 1992-12-28 | 182 | 0 |
| K905401 | ASEPTIMINI UNIT, ADU-10 | Aseptico, Inc. | 1991-02-20 | 79 | 0 |
| K884828 | HANDIDAM | Aseptico, Inc. | 1989-02-03 | 77 | 0 |
| K882526 | DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR. | Aseptico, Inc. | 1988-12-08 | 191 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda