Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Basic Dental Implant Systems, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
268 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K082749 | OMNI-TIGHT | Basic Dental Implant Systems, Inc. | 2008-12-04 | 76 | 0 |
| K072595 | OMNI-TIGHT | Basic Dental Implant Systems, Inc. | 2008-05-09 | 238 | 0 |
| K022912 | POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM | Basic Dental Implant Systems, Inc. | 2002-09-20 | 17 | 0 |
| K013682 | MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM | Basic Dental Implant Systems, Inc. | 2001-11-28 | 21 | 0 |
| K012299 | MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DEN | Basic Dental Implant Systems, Inc. | 2001-08-01 | 12 | 0 |
| K001259 | 2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYST | Basic Dental Implant Systems, Inc. | 2001-01-12 | 268 | 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