Novamin Technology, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Novamin Technology, Inc.” (first 2003, latest 2008), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 57 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 |
|---|---|---|---|
| LBH | Varnish, Cavity | 6 | 6 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 1 | 1 |
Review panels
- Dental (7)
Most recent Novamin Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080228 | ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH | LBH | 2008-03-27 | 57 |
| K071267 | PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN | LBH | 2007-05-18 | 11 |
| K061359 | DENSHIELD TREATMENT FOR SENSITIVE TEETH | LBH | 2006-10-18 | 155 |
| K040858 | ORALIEF THERAPY FOR SENSITIVE TEETH | LBH | 2004-09-02 | 153 |
| K041371 | BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN | EJR | 2004-08-23 | 91 |
| K040473 | ORAVIVE TOOTH REVITALIZING PASTE | LBH | 2004-03-10 | 15 |
| K033295 | BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN | LBH | 2003-10-28 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Novamin Technology, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Novamin Technology, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Novamin Technology, Inc.” (first 2003, latest 2008), 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 Novamin Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Novamin Technology, Inc. is 57 days.
Which FDA product codes appear under Novamin Technology, Inc.?
The most frequent FDA product codes under this applicant name are LBH (Varnish, Cavity, 6); EJR (Agent, Polishing, Abrasive, Oral Cavity, 1).
Next steps
- See all 7 Novamin Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LBH, Novamin Technology, 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.