Lee Pharmaceuticals: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Lee Pharmaceuticals” (first 1976, latest 1993), across 11 product codes in 1 review panel. Median 510(k) review time under this name: 53 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 | 8 | 8 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 5 | 5 |
| KLE | Agent, Tooth Bonding, Resin | 5 | 5 |
| DZS | Capsule, Dental, Amalgam | 2 | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 2 | 2 |
| EJJ | Alloy, Amalgam | 2 | 2 |
| DYW | Bracket, Plastic, Orthodontic | 1 | 1 |
| EBD | Coating, Filling Material, Resin | 1 | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| EID | Syringe, Restorative And Impression Material | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (29)
Most recent Lee Pharmaceuticals 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K924378 | RESTOBOND 4 | KLE | 1993-03-31 | 212 |
| K912256 | PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT | KLE | 1991-07-24 | 63 |
| K900809 | LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS | DYW | 1990-06-28 | 127 |
| K894315 | RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT | KLE | 1989-10-31 | 109 |
| K881903 | PROSTHODENT VL | EBF | 1988-07-01 | 56 |
| K873123 | LEE COMPOSITE INLAY SYSTEM | EBF | 1988-01-20 | 163 |
| K863157 | RESTODENT POSTERIOR | EBF | 1986-09-25 | 41 |
| K854882 | PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT | EBC | 1986-01-30 | 55 |
| K844134 | CLEANSE N BOND II | DYH | 1985-01-04 | 73 |
| K844133 | CLEANSE N BOND I | DYH | 1985-01-04 | 73 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lee Pharmaceuticals.
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 Lee Pharmaceuticals?
FDA lists 29 510(k) clearances under the applicant name “Lee Pharmaceuticals” (first 1976, latest 1993), across 11 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 Lee Pharmaceuticals?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lee Pharmaceuticals is 53 days.
Which FDA product codes appear under Lee Pharmaceuticals?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 8); DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 5); KLE (Agent, Tooth Bonding, Resin, 5).
Next steps
- See all 29 Lee Pharmaceuticals clearances with predicates and recalls
- Run predicate analysis for product code EBF, Lee Pharmaceuticals'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.