Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
ELB · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
195 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170596 | TN-Brush | Genoss Co., Ltd. | 2017-09-11 | 195 | 0 |
| K121114 | TIGRAN PERIBRUSH | Tigran Technologies AB | 2012-09-17 | 158 | 0 |
| K111724 | STRAUMANN TIBRUSH | Straumann USA | 2011-09-12 | 84 | 0 |
| K003640 | MINIENDO III | Sybron Dental Specialties, Inc. | 2001-02-22 | 87 | 0 |
| K831037 | AIR BURBINE HANDPIECE-DENTAL SCALING | Taco Dental, Inc. | 1983-05-09 | 39 | 0 |
| K782007 | ROTARY SCALER | Star Dental Mfg. Co. | 1979-01-03 | 33 | 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