Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EIC — Predicate Candidate Screening
16 FDA 510(k) clearances under this product code; the 50 most recent screened below.
23 daysmedian FDA review time
66 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972234 | RCT GEL ROOT CANAL THERAPY GEL | Dentsply Intl. | 1997-06-30 | 14 | 0 |
| K864307 | MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI) | Smith & Nephew, Inc. | 1986-11-18 | 15 | 0 |
| K861846 | HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT | Solar Dental Co., Inc. | 1986-06-26 | 44 | 0 |
| K851944 | MAX-I-PROBE HANDPIECE | Solo Pak Laboratories | 1985-07-01 | 59 | 0 |
| K840237 | MAX-I-PROBE PERIODONTAL ENDODONTIC PROB | Smith & Nephew, Mpl Division | 1984-04-05 | 76 | 0 |
| K811889 | R & S SERIES FITTING TOOLS | Suncoast Dental Corp. | 1981-07-24 | 23 | 0 |
| K811594 | WATER PISTOL | Aus-Tex Dental Mfg. & Design | 1981-07-15 | 37 | 0 |
| K801484 | ROOT CANAL FILLING APPLICATOR NEEDLES | National Patent Development Corp. | 1980-07-21 | 66 | 0 |
| K801483 | MARK IV SYRINGE | National Patent Development Corp. | 1980-07-21 | 66 | 0 |
| K792578 | EPIC CANNULA | Dental Development Services, Inc. | 1980-01-04 | 21 | 0 |
| K792577 | ENDOVAGE SYRINGE | Dental Development Services, Inc. | 1980-01-04 | 21 | 0 |
| K792461 | CENTRIX MKIV ENDODONTIC DELIVERY | Centrix, Inc. | 1979-12-19 | 16 | 0 |
| K771406 | GUTTA GUN | Aus-Tex Dental Mfg. & Design | 1977-08-26 | 28 | 0 |
| K770967 | SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE | National Patent Development Corp. | 1977-06-20 | 20 | 0 |
| K770813 | ENDOGATOR | Aus-Tex Dental Mfg. & Design | 1977-05-20 | 17 | 0 |
| K770642 | SYRINGE, ENDODONTIC W/NOTCHED TIP NEEDLE | National Patent Development Corp. | 1977-04-15 | 11 | 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