Block Drug Company, Inc.: FDA clearances and approvals
Block Drug Company, Inc. has 10 FDA 510(k) clearances (first 1978, latest 1994), across 8 product codes in 1 review panel. Median 510(k) review time: 56 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 |
|---|---|---|---|
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 2 | 2 |
| KOT | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium | 2 | 2 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| EFT | Cleanser, Denture, Over The Counter | 1 | 1 |
| EFW | Toothbrush, Manual | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
| KOO | Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (9)
Most recent Block Drug Company, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945462 | SUPER POLI-GRIP DENTURE ADHESIVE CREAM | KOT | 1994-12-20 | 43 |
| K935925 | VISION PROPHY PASTE WITH FLUORIDE | EJR | 1994-01-26 | 44 |
| K933893 | VISION PROPHY PASTE WITHOUT FLUORIDE | EJR | 1993-11-16 | 98 |
| K884533 | SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM | KLE | 1989-04-12 | 166 |
| K881974 | PROFICIENT(TM) PROPHYLAXIS ANGLE | EFB | 1988-07-25 | 75 |
| K872225 | SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER | KOT | 1987-06-30 | 21 |
| K862876 | NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM | KOO | 1986-08-29 | 30 |
| K800831 | PY-CO-PROX TM DENTAL BRUSH | EFW | 1980-05-08 | 24 |
| K791064 | DUO TWO LAYER DENTURE CLEANSER | EFT | 1979-10-09 | 120 |
| K780849 | DENTROL LIQUID DENTURE ADHESIVE | — | 1978-07-31 | 69 |
Recalls
openFDA lists no recalls under a recalling firm named Block Drug Company, Inc..
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 Block Drug Company, Inc. have?
Block Drug Company, Inc. has 10 FDA 510(k) clearances (first 1978, latest 1994), across 8 product codes in 1 review panel.
How long does FDA take to clear Block Drug Company, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Block Drug Company, Inc.'s cleared 510(k)s is 56 days.
What devices does Block Drug Company, Inc. make?
Its most frequent FDA product codes are EJR (Agent, Polishing, Abrasive, Oral Cavity, 2); KOT (Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium, 2); EFB (Handpiece, Air-Powered, Dental, 1).
Has Block Drug Company, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Block Drug Company, Inc. Related entities may recall under other names.
Next steps
- See all 10 Block Drug Company, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EJR, Block Drug Company, Inc.'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.