Apex Dental Materials, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Apex Dental Materials, Inc.” (first 2001, latest 2019), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 104 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 | 1 | 91 |
| 2013 | 2 | 141 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 333 |
| 2018 | 0 | — |
| 2019 | 1 | 206 |
| 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 Apex Dental Materials, Inc. took a median 270 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 111 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | 8 | 8 |
| EBF | Material, Tooth Shade, Resin | 5 | 5 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 1 | 1 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
Review panels
- Dental (15)
Most recent Apex Dental Materials, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190998 | BA Pit & Fissure Sealant | EBC | 2019-11-08 | 206 |
| K161077 | RnD TE and RnD SE | KLE | 2017-03-17 | 333 |
| K131043 | APEX UNIVERSAL ADHESIVE | KLE | 2013-09-10 | 148 |
| K131049 | ZRP | KLE | 2013-08-27 | 134 |
| K120620 | CLEAN AND BOOST | KLE | 2012-05-31 | 91 |
| K110859 | METAL OPAQUER | EBF | 2011-06-23 | 87 |
| K092539 | SEAMFREE | EBF | 2009-10-01 | 43 |
| K091647 | INJECTAFIL | EBF | 2009-09-21 | 104 |
| K062157 | CONFORM | EBF | 2006-10-13 | 77 |
| K061981 | SURPASS | KLE | 2006-07-31 | 18 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Apex Dental Materials, 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.
- Apex Medical Corp. (36 510(k)s)
- Apex BioTechnology Corp. (35 510(k)s)
- Apex Medical Technologies, Inc. (8 510(k)s)
- Apex Surgical, LLC (6 510(k)s)
- Apex Metal, Inc. (3 510(k)s)
- Apex Tools & Orthopedics Co. (2 510(k)s)
- Apex Ent., Inc. (1 510(k)s)
- Apex Imaging Corp. (1 510(k)s)
- Apex Medical Products, LLC (1 510(k)s)
- Apex Optical Ind. Co. (1 510(k)s)
- Apex Orthodontics, Inc. (1 510(k)s)
- Apex Technologies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Apex Dental Materials, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Apex Dental Materials, Inc.” (first 2001, latest 2019), across 4 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 Apex Dental Materials, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Apex Dental Materials, Inc. is 104 days.
Which FDA product codes appear under Apex Dental Materials, Inc.?
The most frequent FDA product codes under this applicant name are KLE (Agent, Tooth Bonding, Resin, 8); EBF (Material, Tooth Shade, Resin, 5); DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 1).
Next steps
- See all 15 Apex Dental Materials, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KLE, Apex Dental Materials, 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.