Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wilde-USA, Inc. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
164 daysmedian FDA review time
564 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K913582 | COMPATIT R | Wilde-USA, Inc. | 1993-06-24 | 682 | 0 |
| K915653 | KERAMAIL | Wilde-USA, Inc. | 1993-04-08 | 477 | 0 |
| K913581 | WILDE ADHESIVE BONDING SYSTEM | Wilde-USA, Inc. | 1993-02-26 | 564 | 0 |
| K923472 | COMPACOLOR | Wilde-USA, Inc. | 1992-10-13 | 91 | 0 |
| K920649 | COMPASEP | Wilde-USA, Inc. | 1992-07-23 | 162 | 0 |
| K915250 | WIL-PDS & WIL-PDI CASTING ALLOYS | Wilde-USA, Inc. | 1992-04-21 | 158 | 0 |
| K913089 | WILDE LIGHT CURING COMPOSITE RESTORATIVE RESINS | Wilde-USA, Inc. | 1992-04-21 | 284 | 0 |
| K912990 | CONVERBASE | Wilde-USA, Inc. | 1992-03-25 | 261 | 0 |
| K920557 | WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX | Wilde-USA, Inc. | 1992-03-20 | 44 | 0 |
| K915654 | KERALLOY-D CAPS | Wilde-USA, Inc. | 1992-03-02 | 75 | 0 |
| K912993 | WILDE DENTURE RESINS | Wilde-USA, Inc. | 1992-02-03 | 210 | 0 |
| K912994 | COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE | Wilde-USA, Inc. | 1991-12-23 | 168 | 0 |
| K912991 | WILDE AUXILIARIES | Wilde-USA, Inc. | 1991-12-19 | 164 | 0 |
| K912992 | KERALLOY NON-GAMMA 2 AMALGAM | Wilde-USA, Inc. | 1991-11-13 | 128 | 0 |
| K913583 | CONVERSIL FL AND CONVERSIL P | Wilde-USA, Inc. | 1991-11-13 | 93 | 0 |
| K912989 | PLANUSTAR AND DENS NOBILIS DENTURE TEETH | Wilde-USA, Inc. | 1991-08-16 | 39 | 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