Dent Zar, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Dent Zar, Inc.” (first 1989, latest 1996), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 74 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 10 | 10 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
Review panels
- Dental (12)
Most recent Dent Zar, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962277 | SELF CURE BONDING AGENT | KLE | 1996-07-03 | 20 |
| K960729 | ENAMEL CONDITIONER (ENAMEL ETCHING AGENT) | EBF | 1996-04-26 | 64 |
| K960600 | LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS | EBF | 1996-04-26 | 74 |
| K960599 | SUPERIOR PHOTOCURING HYBRID COMPOSITE | EBF | 1996-04-26 | 74 |
| K960598 | CONCORD MARYLAND BRIDGE CEMENT | EBF | 1996-04-26 | 74 |
| K960597 | ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CURE | EBF | 1996-04-26 | 74 |
| K960596 | ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE | EBF | 1996-04-26 | 74 |
| K960595 | FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS | EBF | 1996-04-26 | 74 |
| K960594 | LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETS | EBF | 1996-04-26 | 74 |
| K960565 | ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE | EBF | 1996-03-22 | 42 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dent Zar, 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.
- Dent Corp. Research & Development (3 510(k)s)
- Dent'N CO (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dent Zar, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Dent Zar, Inc.” (first 1989, latest 1996), across 3 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 Dent Zar, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dent Zar, Inc. is 74 days.
Which FDA product codes appear under Dent Zar, Inc.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 10); DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 1); KLE (Agent, Tooth Bonding, Resin, 1).
Next steps
- See all 12 Dent Zar, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Dent Zar, 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.