Sci-Pharm, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Sci-Pharm, Inc.” (first 1981, latest 1983), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 21 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 |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 5 | 5 |
| EBF | Material, Tooth Shade, Resin | 5 | 5 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 2 | 2 |
| LBH | Varnish, Cavity | 2 | 2 |
| EMA | Cement, Dental | 1 | 1 |
Review panels
- Dental (15)
Most recent Sci-Pharm, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K823935 | MICRO JOIN, CROWN & BRIDGE ADHESIVE | EMA | 1983-02-07 | 40 |
| K820092 | SECURE-ON-TOUCH | DYH | 1982-02-24 | 42 |
| K813091 | FISSURE SEALER & BONDING AGENT | EBC | 1981-11-24 | 22 |
| K813090 | COMPOSITE DENTAL RESTORATIVE MATERIAL | EBF | 1981-11-24 | 22 |
| K812550 | BEAUCAV | LBH | 1981-09-25 | 21 |
| K812549 | BEAUSEAL | EBC | 1981-09-25 | 21 |
| K812548 | COBEAU | LBH | 1981-09-25 | 21 |
| K812546 | BEAUDENT | EBF | 1981-09-25 | 21 |
| K812545 | BEAUFILL | EBF | 1981-09-25 | 21 |
| K812551 | BEAUCOR | EBF | 1981-09-23 | 19 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sci-Pharm, 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 Sci-Pharm, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Sci-Pharm, Inc.” (first 1981, latest 1983), across 5 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 Sci-Pharm, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sci-Pharm, Inc. is 21 days.
Which FDA product codes appear under Sci-Pharm, Inc.?
The most frequent FDA product codes under this applicant name are DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 5); EBF (Material, Tooth Shade, Resin, 5); EBC (Sealant, Pit And Fissure, And Conditioner, 2).
Next steps
- See all 15 Sci-Pharm, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYH, Sci-Pharm, 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.