Sterngold: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Sterngold” (first 1995, latest 2009), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 7 | 7 |
| EJT | Alloy, Gold-Based Noble Metal | 3 | 3 |
| EJS | Alloy, Other Noble Metal | 2 | 2 |
Review panels
- Dental (12)
Most recent Sterngold 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092434 | STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM | DZE | 2009-11-10 | 95 |
| K041271 | STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM | DZE | 2004-10-28 | 169 |
| K023580 | STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM | DZE | 2003-01-17 | 85 |
| K022252 | STERNGOLD 1, MODEL 1127781 | EJS | 2002-09-19 | 69 |
| K021741 | CRITERTION, MODEL #1067511 | EJT | 2002-06-26 | 29 |
| K021045 | ERA IMPLANT | DZE | 2002-06-26 | 86 |
| K021367 | STERNGOLD 66, MODEL #1180230 | EJS | 2002-05-16 | 16 |
| K020949 | APOLLO, MODEL 1124525 | EJT | 2002-04-04 | 10 |
| K020391 | STERN MICRO ERA ATTACHMENT SYSTEM | DZE | 2002-03-08 | 30 |
| K003007 | GALAXY | EJT | 2000-11-17 | 52 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sterngold.
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.
- Sterngold/Implamed (16 510(k)s)
- Sterngold Dental, LLC (12 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sterngold?
FDA lists 12 510(k) clearances under the applicant name “Sterngold” (first 1995, latest 2009), across 3 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?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sterngold is 60 days.
Which FDA product codes appear under Sterngold?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 7); EJT (Alloy, Gold-Based Noble Metal, 3); EJS (Alloy, Other Noble Metal, 2).
Next steps
- See all 12 Sterngold clearances with predicates and recalls
- Run predicate analysis for product code DZE, Sterngold'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.