Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
L.D. Caulk Co. · Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
18 daysmedian FDA review time
50 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K802262 | COMPOSITE RESTORATIVE | L.D. Caulk Co. | 1980-09-16 | 0 | 0 |
| K801690 | VALIANT | L.D. Caulk Co. | 1980-08-13 | 21 | 0 |
| K790585 | FINESSE | L.D. Caulk Co. | 1979-05-16 | 50 | 0 |
| K790586 | CHEMBOND | L.D. Caulk Co. | 1979-05-16 | 50 | 0 |
| K780560 | DENTAL AMALGAMATOR | L.D. Caulk Co. | 1978-04-21 | 16 | 0 |
| K780384 | IMPROVED DYCAL | L.D. Caulk Co. | 1978-03-15 | 6 | 0 |
| K780301 | CAULK TYLOK | L.D. Caulk Co. | 1978-02-28 | 6 | 0 |
| K771399 | LIP & CHEEK RETRACTOR | L.D. Caulk Co. | 1977-08-26 | 28 | 0 |
| K771398 | SHELL VENEER | L.D. Caulk Co. | 1977-08-26 | 28 | 0 |
| K771402 | NUVA-COTE (MODIFICATION TO) | L.D. Caulk Co. | 1977-08-26 | 28 | 0 |
| K771403 | EASE (MODIFICATION TO) | L.D. Caulk Co. | 1977-08-22 | 24 | 0 |
| K771400 | IMPREGNATED DENTAL FLOSS | L.D. Caulk Co. | 1977-08-22 | 24 | 0 |
| K771401 | PROPHY PASTE | L.D. Caulk Co. | 1977-08-22 | 24 | 0 |
| K771404 | NUVA-FIL COMPOSITE RESTORATIVE (MODI.) | L.D. Caulk Co. | 1977-08-03 | 5 | 0 |
| K760400 | BONDING AGENT, VYTOL | L.D. Caulk Co. | 1976-08-23 | 17 | 0 |
| K760379 | DENTAL AMALGAM ALLOY (SPHERICAL II) | L.D. Caulk Co. | 1976-08-23 | 18 | 0 |
| K760378 | CEMENT, RESIN DENTAL (AUTO-TACH) | L.D. Caulk Co. | 1976-08-23 | 18 | 0 |
| K760377 | FILLING, RESIN DENTAL (VYTOL) | L.D. Caulk Co. | 1976-08-23 | 18 | 0 |
| K760405 | SEALANT, NEW FILLED | L.D. Caulk Co. | 1976-08-23 | 14 | 0 |
| K760376 | CEMENT, RESIN DENTAL (SOLO-TACH) | L.D. Caulk Co. | 1976-08-23 | 18 | 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