Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EKM — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
57 daysmedian FDA review time
158 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K073369 | EI DOWNPAK BARRIER SLEEVES | Hu-Friedy Mfg. Co., Inc. | 2008-02-27 | 89 | 0 |
| K070246 | DOWN PAK | Endo Twinn B.V. | 2007-02-16 | 22 | 0 |
| K051573 | TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) | Dr. Howard Martin, P.A. | 2006-06-26 | 377 | 0 |
| K042870 | ENDO TWINN | Endo Twinn B.V. | 2005-01-11 | 85 | 0 |
| K023819 | FIBERFILL SGP | Pentron Clinical Technologies | 2003-03-26 | 131 | 1 |
| K971641 | ANTIBACTERIAL GUTTA PERCHA | Dr. Howard Martin, P.A. | 1997-07-21 | 80 | 0 |
| K970134 | THERMAPREP PLUS OVEN | Tulsa Dental Products, Ltd. | 1997-03-21 | 65 | 0 |
| K931742 | INJECT-R FILL | Union Broach, Div. Moyco Industries, Inc. | 1993-05-27 | 50 | 0 |
| K924825 | MICRODOSE RC-EZ | Unicep | 1993-03-05 | 158 | 0 |
| K915243 | TOUCH 'N HEAT MODEL 5002, MODIFICATION | Analytic Technology | 1992-01-21 | 82 | 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 |
| K896663 | ENDO-PREP | Pulpdent Corp. | 1990-02-14 | 82 | 0 |
| K881139 | THERMAFIL ENDODONTIC OBTURATOR | Tulsa Dental Products, Ltd. | 1988-04-07 | 21 | 0 |
| K863638 | GUTTA PERCHA POINTS | Endodent, Inc. | 1986-10-30 | 43 | 0 |
| K863411 | GUTTA PERCHA | Endodent, Inc. | 1986-10-30 | 57 | 0 |
| K862129 | SET CANAL SEALER PASTE | Endo Technic Corp. | 1986-07-22 | 48 | 0 |
| K850863 | ULTRAFIL-LT (GUTTA PERCHA) | The Hygenic Corp. | 1985-04-16 | 46 | 0 |
| K832654 | HEATED GUTTA PERCHA DELIVERY SYSTEM | Unitek Corp. | 1983-09-26 | 49 | 0 |
| K830114 | GUTTA PERCHA POINTS | North Pacific Dental, Inc. | 1983-03-01 | 49 | 0 |
| K830115 | PAPER POINTS | North Pacific Dental, Inc. | 1983-03-01 | 49 | 0 |
| K823486 | TOUCH-N-HEAT MODEL 5001 | Analytic Technology | 1983-01-18 | 56 | 0 |
| K820639 | OBTURATION SYSTEM KIT | U.S. Shizai Corp. | 1982-04-09 | 32 | 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