Ultradent Products, Inc.: FDA filings under this applicant name
FDA lists 104 510(k) clearances under the applicant name “Ultradent Products, Inc.” (first 1992, latest 2026), across 22 product codes in 1 review panel. Median 510(k) review time under this name: 74 days. Since 2017 the median was 4 days, against 126 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 | 2 | 116 |
| 2014 | 0 | — |
| 2015 | 2 | 76 |
| 2016 | 1 | 135 |
| 2017 | 0 | — |
| 2018 | 1 | 133 |
| 2019 | 1 | 48 |
| 2020 | 0 | — |
| 2021 | 3 | 78 |
| 2022 | 2 | 2 |
| 2023 | 0 | — |
| 2024 | 2 | 2 |
| 2025 | 0 | — |
| 2026 | 2 | 1 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ultradent Products, Inc. took a median 4 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | 19 | 19 |
| EBF | Material, Tooth Shade, Resin | 17 | 17 |
| EMA | Cement, Dental | 9 | 9 |
| LBH | Varnish, Cavity | 9 | 9 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 7 | 7 |
| EBZ | Activator, Ultraviolet, For Polymerization | 7 | 7 |
| EJK | Liner, Cavity, Calcium Hydroxide | 5 | 5 |
| KIF | Resin, Root Canal Filling | 5 | 5 |
| KJJ | Cleanser, Root Canal | 5 | 5 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 4 | 4 |
Plus 12 more product codes.
Review panels
- Dental (104)
Most recent Ultradent Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262228 | Transcend Bulk Fill Flowable Composite | EBF | 2026-07-01 | 1 |
| K261404 | UltraEZ | LBH | 2026-04-30 | 1 |
| K240743 | Peak Universal Bond | KLE | 2024-03-20 | 2 |
| K240694 | FORMA Composite (Shade A3D) | EBF | 2024-03-15 | 1 |
| K221909 | J-Temp | EBF | 2022-07-01 | 1 |
| K220471 | VALO X, VALO X Accessory Lenses | EBZ | 2022-02-22 | 4 |
| K211905 | UltraCal XS | KIF | 2021-10-13 | 114 |
| K211237 | UltraTemp Rez II | EMA | 2021-07-13 | 78 |
| K210550 | VALO Grand Corded and Accessory Lenses | EBZ | 2021-03-01 | 4 |
| K190627 | VALO Grand Corded | EBZ | 2019-04-29 | 48 |
94 earlier clearances. See the full list in Caduvo.
Recalls
20 product recalls in 13 recall events; 5 initiated in the last five years. Most recent: 2026-01-28.
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.
- Ultradent Product, Inc. (2 510(k)s)
- Ultradent Products Inc. / Oratech, LLC (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ultradent Products, Inc.?
FDA lists 104 510(k) clearances under the applicant name “Ultradent Products, Inc.” (first 1992, latest 2026), across 22 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 Ultradent Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ultradent Products, Inc. is 74 days. Since 2017: 4 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ultradent Products, Inc.?
The most frequent FDA product codes under this applicant name are KLE (Agent, Tooth Bonding, Resin, 19); EBF (Material, Tooth Shade, Resin, 17); EMA (Cement, Dental, 9).
Next steps
- See all 104 Ultradent Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KLE, Ultradent Products, 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, 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.