Wilde-USA, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Wilde-USA, Inc.” (first 1991, latest 1993), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 163 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 4 | 4 |
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| EJJ | Alloy, Amalgam | 2 | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| EIH | Powder, Porcelain | 1 | 1 |
| EJH | Alloy, Metal, Base | 1 | 1 |
| ELM | Denture, Plastic, Teeth | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
| EMI | File, Bone, Surgical | 1 | 1 |
| FMC | Patient Examination Glove | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (15)
- General Hospital (1)
Most recent Wilde-USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913582 | COMPATIT R | ELM | 1993-06-24 | 682 |
| K915653 | KERAMAIL | EIH | 1993-04-08 | 477 |
| K913581 | WILDE ADHESIVE BONDING SYSTEM | KLE | 1993-02-26 | 564 |
| K923472 | COMPACOLOR | EBF | 1992-10-13 | 91 |
| K920649 | COMPASEP | FMC | 1992-07-23 | 162 |
| K915250 | WIL-PDS & WIL-PDI CASTING ALLOYS | EJH | 1992-04-21 | 158 |
| K913089 | WILDE LIGHT CURING COMPOSITE RESTORATIVE RESINS | EBF | 1992-04-21 | 284 |
| K912990 | CONVERBASE | EBI | 1992-03-25 | 261 |
| K920557 | WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX | EBI | 1992-03-20 | 44 |
| K915654 | KERALLOY-D CAPS | EJJ | 1992-03-02 | 75 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Wilde-USA, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Wilde Dental (Usa) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Wilde-USA, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Wilde-USA, Inc.” (first 1991, latest 1993), across 11 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Wilde-USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wilde-USA, Inc. is 163 days.
Which FDA product codes appear under Wilde-USA, Inc.?
The most frequent FDA product codes under this applicant name are EBI (Resin, Denture, Relining, Repairing, Rebasing, 4); EBF (Material, Tooth Shade, Resin, 2); EJJ (Alloy, Amalgam, 2).
Next steps
- See all 16 Wilde-USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBI, Wilde-USA, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.