Discus Dental, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Discus Dental, Inc.” (first 2002, latest 2010), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | 3 | 3 |
| ELW | Material, Impression | 3 | 3 |
| ELC | Scaler, Ultrasonic | 2 | 2 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 1 | 1 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| KIF | Resin, Root Canal Filling | 1 | 1 |
| LBH | Varnish, Cavity | 1 | 1 |
| MED | Sterilant, Medical Devices | 1 | 1 |
Review panels
- Dental (13)
- General Hospital (1)
- General and Plastic Surgery (1)
Most recent Discus Dental, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102639 | SL3 | GEX | 2010-12-01 | 78 |
| K101612 | ZEN CORDLESS PROPHY SYSTEM | EKX | 2010-06-30 | 21 |
| K101215 | NUANCE | EBF | 2010-05-12 | 12 |
| K093208 | SIMPLISEAL | KIF | 2010-02-12 | 122 |
| K092417 | INSIGHT ULTRASONIC INSERTS | ELC | 2009-12-11 | 126 |
| K073518 | FLASHLITE REBEL* | EBZ | 2007-12-20 | 6 |
| K062176 | RELIEF ACP ORAL CARE GEL | LBH | 2007-01-10 | 163 |
| K052090 | SPLASH! IMPRESSION MATERIAL DEVICE | ELW | 2005-08-05 | 3 |
| K051776 | PROTEGE ULTRASONIC INSERT | ELC | 2005-07-13 | 12 |
| K033785 | PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE | EJR | 2004-06-18 | 197 |
5 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2014-10-24.
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 Discus Dental, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Discus Dental, Inc.” (first 2002, latest 2010), across 10 product codes in 3 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 Discus Dental, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Discus Dental, Inc. is 70 days.
Which FDA product codes appear under Discus Dental, Inc.?
The most frequent FDA product codes under this applicant name are EBZ (Activator, Ultraviolet, For Polymerization, 3); ELW (Material, Impression, 3); ELC (Scaler, Ultrasonic, 2).
Next steps
- See all 15 Discus Dental, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBZ, Discus 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, 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.