Confi-Dental Products Co.: FDA clearances and approvals
Confi-Dental Products Co. has 31 FDA 510(k) clearances (first 1989, latest 2003), across 9 product codes in 1 review panel. Median 510(k) review time: 90 days.
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 |
|---|---|---|---|
| EMA | Cement, Dental | 8 | 8 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 6 | 6 |
| EBF | Material, Tooth Shade, Resin | 6 | 6 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 4 | 4 |
| ELW | Material, Impression | 2 | 2 |
| KLE | Agent, Tooth Bonding, Resin | 2 | 2 |
| KIF | Resin, Root Canal Filling | 1 | 1 |
| KZP | Solution, Cement Dissolving | 1 | 1 |
| LFC | Device, Caries Detection | 1 | 1 |
Review panels
- Dental (31)
Most recent Confi-Dental Products Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030807 | CARIES INDICATOR | LFC | 2003-06-09 | 88 |
| K030743 | ETCHANT 40% | KLE | 2003-05-09 | 60 |
| K955329 | RESILIENCE M5 PROTECTION PLUS | DYH | 1996-03-28 | 129 |
| K955328 | CONFI-BOND | KLE | 1996-03-28 | 129 |
| K954988 | CRYSTALLESSENCE | EBF | 1996-03-08 | 129 |
| K952930 | DENTRAY II PLUS TRAY ADHESIVE | ELW | 1995-09-08 | 81 |
| K946307 | CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE | EBF | 1995-01-26 | 29 |
| K940546 | GRANITEC IONOMER RESIN CEMENT | EMA | 1994-04-29 | 81 |
| K936070 | TREND SET 2 PLUS | ELW | 1994-02-04 | 46 |
| K935714 | CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE | DYH | 1994-01-21 | 52 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Confi-Dental Products Co..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Confi-Dental Products Co. have?
Confi-Dental Products Co. has 31 FDA 510(k) clearances (first 1989, latest 2003), across 9 product codes in 1 review panel.
How long does FDA take to clear Confi-Dental Products Co.'s 510(k)s?
The median time from FDA receipt to decision across Confi-Dental Products Co.'s cleared 510(k)s is 90 days.
What devices does Confi-Dental Products Co. make?
Its most frequent FDA product codes are EMA (Cement, Dental, 8); DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 6); EBF (Material, Tooth Shade, Resin, 6).
Has Confi-Dental Products Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Confi-Dental Products Co. Related entities may recall under other names.
Next steps
- See all 31 Confi-Dental Products Co. clearances with predicates and recalls
- Run predicate analysis for product code EMA, Confi-Dental Products Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.