Millennium Dental Technologies, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Millennium Dental Technologies, Inc.” (first 2001, latest 2019), across 1 product code in 1 review panel. Median 510(k) review time under this name: 260 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 | 1 | 260 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 263 |
| 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 Millennium Dental Technologies, Inc. took a median 263 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 5 | 5 |
Review panels
Most recent Millennium Dental Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182930 | PerioLase Nd:YAG Pulsed Dental Laser System | GEX | 2019-07-12 | 263 |
| K151763 | PerioLase Nd:YAG Pulsed Dental Laser System | GEX | 2016-03-15 | 260 |
| K030290 | PERIOLASE ND:YAG DENTAL LASER SYSTEM | GEX | 2004-07-26 | 550 |
| K014272 | PERIOLASE ND:YAG DENTAL LASER SYSTEM | GEX | 2002-03-27 | 90 |
| K010771 | PERIOLASE ND:YAG DENTAL LASER SYSTEM | GEX | 2001-11-27 | 258 |
Recalls
openFDA lists no recalls under a recalling firm named Millennium Dental Technologies, Inc..
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.
- Millennium Biomedical, Inc. (5 510(k)s)
- Millennium Medical Technologies, Inc. (5 510(k)s)
- Millennium Company, LLC (1 510(k)s)
- Millennium Dental International, Inc. (1 510(k)s)
- Millennium Devices, Inc. (1 510(k)s)
- Millennium Magnetic Imaging, Inc. (1 510(k)s)
- Millennium Medical Distribution, Inc. (1 510(k)s)
- Millennium Medical Technologies Inc (Dba Cellmyx) (1 510(k)s)
- Millennium Technology Services (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Millennium Dental Technologies, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Millennium Dental Technologies, Inc.” (first 2001, latest 2019), across 1 product code 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 Millennium Dental Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Millennium Dental Technologies, Inc. is 260 days.
Which FDA product codes appear under Millennium Dental Technologies, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 5).
Next steps
- See all 5 Millennium Dental Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Millennium Dental Technologies, 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.