Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tulsa Dental Products, Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
708 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970134 | THERMAPREP PLUS OVEN | Tulsa Dental Products, Ltd. | 1997-03-21 | 65 | 0 |
| K964174 | MINERAL TRIOXIDE AGGREGATE (MTA) | Tulsa Dental Products, Ltd. | 1997-02-10 | 115 | 0 |
| K954790 | PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS | Tulsa Dental Products, Ltd. | 1996-01-16 | 89 | 0 |
| K922931 | THERMAPOST ENDODONTIC ROOT CANAL POST | Tulsa Dental Products, Ltd. | 1994-05-26 | 708 | 0 |
| K933582 | PROFILE SERIES 29 FILES | Tulsa Dental Products, Ltd. | 1993-10-20 | 89 | 0 |
| K910224 | THERMAPREP | Tulsa Dental Products, Ltd. | 1991-03-29 | 70 | 0 |
| K900986 | THERMAFIL ENDODONTIC OBTURATOR | Tulsa Dental Products, Ltd. | 1990-11-13 | 257 | 0 |
| K881139 | THERMAFIL ENDODONTIC OBTURATOR | Tulsa Dental Products, Ltd. | 1988-04-07 | 21 | 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