Sterngold/Implamed: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Sterngold/Implamed” (first 1992, latest 1999), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 37 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | 5 | 5 |
| DZE | Implant, Endosseous, Root-Form | 4 | 4 |
| EJS | Alloy, Other Noble Metal | 2 | 2 |
| EMA | Cement, Dental | 2 | 2 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| ELR | Post, Root Canal | 1 | 1 |
Review panels
- Dental (16)
Most recent Sterngold/Implamed 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K984341 | STERNVANTAGE VARNISH LC, MODEL 221001 | EBI | 1999-01-08 | 35 |
| K984340 | STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 | EMA | 1999-01-08 | 35 |
| K983786 | STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION | DZE | 1998-11-13 | 17 |
| K982692 | STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC | EBF | 1998-10-22 | 80 |
| K982895 | STERNOMEGA COMPOMER CEMENT | EMA | 1998-10-09 | 53 |
| K981516 | STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB | DZE | 1998-05-11 | 13 |
| K962326 | STERNGOLD BIO-5 (1127210) | EJT | 1996-07-24 | 37 |
| K962325 | QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015) | EJT | 1996-07-24 | 37 |
| K962324 | STERNGOLD U-CPF METAL ALLOY (1067800) | EJS | 1996-07-24 | 37 |
| K962304 | STERNGOLD BIO-4 | EJS | 1996-07-23 | 36 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sterngold/Implamed.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sterngold/Implamed?
FDA lists 16 510(k) clearances under the applicant name “Sterngold/Implamed” (first 1992, latest 1999), across 7 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 Sterngold/Implamed?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sterngold/Implamed is 37 days.
Which FDA product codes appear under Sterngold/Implamed?
The most frequent FDA product codes under this applicant name are EJT (Alloy, Gold-Based Noble Metal, 5); DZE (Implant, Endosseous, Root-Form, 4); EJS (Alloy, Other Noble Metal, 2).
Next steps
- See all 16 Sterngold/Implamed clearances with predicates and recalls
- Run predicate analysis for product code EJT, Sterngold/Implamed'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.