Metalor Dental USA Corp.: FDA filings under this applicant name
FDA lists 67 510(k) clearances under the applicant name “Metalor Dental USA Corp.” (first 1991, latest 2001), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 52 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 |
|---|---|---|---|
| EJS | Alloy, Other Noble Metal | 31 | 31 |
| EJT | Alloy, Gold-Based Noble Metal | 31 | 31 |
| EGG | Attachment, Precision, All | 2 | 2 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| EJH | Alloy, Metal, Base | 1 | 1 |
| ELR | Post, Root Canal | 1 | 1 |
Review panels
- Dental (67)
Most recent Metalor Dental USA Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003387 | AUROFILM NP | EJH | 2001-01-09 | 70 |
| K993475 | AUROFLUID M, ALLOY NO. 5315 | EJS | 1999-12-09 | 56 |
| K993506 | PAGALINOR 4 , ALLOY NO. 5440 | EJS | 1999-12-08 | 54 |
| K993505 | V-DELTA SPECIAL, ALLOY NO. 5154 | EJS | 1999-12-08 | 54 |
| K993508 | V-SUPRA PLUS, ALLOY NO. 5025 | EJT | 1999-12-06 | 52 |
| K993507 | V-SUPRAGOLD, ALLOY NO. 5024 | EJT | 1999-12-06 | 52 |
| K993474 | DELTAPAL, ALLOY NO. 5161 | EJS | 1999-12-02 | 49 |
| K982606 | AUROFLUID CPF | EJT | 1998-10-15 | 80 |
| K973372 | AUROFILM 2000 | EJT | 1997-11-26 | 79 |
| K972683 | V-DELTA 450 | EJS | 1997-08-18 | 32 |
57 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Metalor Dental USA Corp..
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.
- Metalor Technologies USA (4 510(k)s)
- Metalor (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Metalor Dental USA Corp.?
FDA lists 67 510(k) clearances under the applicant name “Metalor Dental USA Corp.” (first 1991, latest 2001), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Metalor Dental USA Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Metalor Dental USA Corp. is 52 days.
Which FDA product codes appear under Metalor Dental USA Corp.?
The most frequent FDA product codes under this applicant name are EJS (Alloy, Other Noble Metal, 31); EJT (Alloy, Gold-Based Noble Metal, 31); EGG (Attachment, Precision, All, 2).
Next steps
- See all 67 Metalor Dental USA Corp. clearances with predicates and recalls
- Run predicate analysis for product code EJS, Metalor Dental USA Corp.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.