Keystone Dental, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under 2 spellings of the applicant name “Keystone Dental, Inc.” (first 2007, latest 2024), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 100 days. Since 2017 the median was 90 days, against 155 days for all cleared 510(k)s in the same product codes. 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 | 1 | 90 |
| 2021 | 0 | — |
| 2022 | 1 | 89 |
| 2023 | 1 | 156 |
| 2024 | 1 | 91 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Keystone Dental, Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 155 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 5 | 5 |
| NHA | Abutment, Implant, Dental, Endosseous | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
Most recent Keystone Dental, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240966 | Prima Plus Conical Implant System | DZE | 2024-07-09 | 91 |
| K223814 | Genesis ACTIVE Implant System | DZE | 2023-05-25 | 156 |
| K221381 | KDG Abutments | NHA | 2022-08-10 | 89 |
| K201334 | Keystone Dental XL Dental Implant System | DZE | 2020-08-18 | 90 |
| K101545 | GENESIS IMPLANT SYSTEM | DZE | 2010-10-28 | 147 |
| K090397 | XPI ANGLED ABUTMENTS | NHA | 2009-06-05 | 108 |
| K071070 | OLYMPUS DENTAL IMPLANT SYSTEM | DZE | 2007-10-23 | 190 |
| K071599 | EASYGUIDE | LLZ | 2007-07-11 | 30 |
Recalls
16 product recalls in 12 recall events; 0 initiated in the last five years. Most recent: 2019-02-22.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Keystone Dental, Inc. (7)
- Keystone Dental (1)
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.
- Keystone X-Ray, Inc. (4 510(k)s)
- Keystone Industries (3 510(k)s)
- Keystone Veterinary Supplies, Inc. (3 510(k)s)
- Keystone Diagnostics, Inc. (2 510(k)s)
- Keystone Medical (2 510(k)s)
- Keystone Heart, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Keystone Dental, Inc.?
FDA lists 8 510(k) clearances under 2 spellings of the applicant name “Keystone Dental, Inc.” (first 2007, latest 2024), across 3 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 Keystone Dental, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Keystone Dental, Inc. is 100 days. Since 2017: 90 days, versus 155 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Keystone Dental, Inc.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 5); NHA (Abutment, Implant, Dental, Endosseous, 2); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 8 Keystone Dental, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Keystone Dental, 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.