Sterngold Dental, LLC: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Sterngold Dental, LLC” (first 2012, latest 2017), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 121 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 | 1 | 340 |
| 2013 | 2 | 148 |
| 2014 | 3 | 124 |
| 2015 | 4 | 112 |
| 2016 | 1 | 94 |
| 2017 | 1 | 108 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sterngold Dental, LLC took a median 108 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 191 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 6 | 6 |
| NHA | Abutment, Implant, Dental, Endosseous | 6 | 6 |
Review panels
- Dental (12)
Most recent Sterngold Dental, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171728 | MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm | DZE | 2017-09-28 | 108 |
| K153173 | MOR Implant System | DZE | 2016-02-05 | 94 |
| K151928 | PUR Dental Implant System | DZE | 2015-11-06 | 115 |
| K150968 | TRU Dental Implant System | DZE | 2015-07-24 | 102 |
| K150250 | SternSnap Angled Attachment | NHA | 2015-06-11 | 128 |
| K142667 | Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm | DZE | 2015-01-07 | 110 |
| K142407 | Straight Stud Attachment | NHA | 2014-12-24 | 118 |
| K133791 | ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S] | NHA | 2014-04-16 | 124 |
| K132814 | SFI-BAR IMPLANT ABUTMENTS | NHA | 2014-02-25 | 169 |
| K130183 | SFI BAR ABUTMENTS | NHA | 2013-07-07 | 163 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sterngold Dental, LLC.
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 (12 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sterngold Dental, LLC?
FDA lists 12 510(k) clearances under the applicant name “Sterngold Dental, LLC” (first 2012, latest 2017), across 2 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 Dental, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sterngold Dental, LLC is 121 days.
Which FDA product codes appear under Sterngold Dental, LLC?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 6); NHA (Abutment, Implant, Dental, Endosseous, 6).
Next steps
- See all 12 Sterngold Dental, LLC clearances with predicates and recalls
- Run predicate analysis for product code DZE, Sterngold Dental, LLC'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.