Lee Pharmaceuticals
Mchenry, IL, US
Lee Pharmaceuticals appears in FDA device records in Mchenry, IL. FDA records list 29 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 29
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 29 510(k) clearances for Lee Pharmaceuticals between 1976 and 1993. The busiest year on record is 1978, with 7. The most recent is 1993, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 4 |
| 1977 | 4 |
| 1978 | 7 |
| 1981 | 2 |
| 1984 | 2 |
| 1985 | 2 |
| 1986 | 2 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1993 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K924378 | RESTOBOND 4 | KLE | Substantially Equivalent | |
| K912256 | PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT | KLE | Substantially Equivalent | |
| K900809 | LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS | DYW | Substantially Equivalent | |
| K894315 | RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT | KLE | Substantially Equivalent | |
| K881903 | PROSTHODENT VL | EBF | Substantially Equivalent | |
| K873123 | LEE COMPOSITE INLAY SYSTEM | EBF | Substantially Equivalent | |
| K863157 | RESTODENT POSTERIOR | EBF | Substantially Equivalent | |
| K854882 | PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT | EBC | Substantially Equivalent | |
| K844134 | CLEANSE N BOND II | DYH | Substantially Equivalent | |
| K844133 | CLEANSE N BOND I | DYH | Substantially Equivalent | |
| K843363 | RESTODENT VL | EBF | Substantially Equivalent | |
| K840726 | RESTODENT DENTIN BONDING AGENT | KLE | Substantially Equivalent | |
| K810923 | LEE ENDOFILL, ROOT CANAL FILLING RESIN | KIF | Substantially Equivalent | |
| K810517 | INSTA-BOND | DYH | Substantially Equivalent | |
| K781977 | APPLICATOR, LEE IMPRESSION | EID | Substantially Equivalent | |
| K781243 | MERCURY DISP. CAPSULE | DZS | Substantially Equivalent | |
| K781242 | ALLOY, AMALGAM, DISP. CAPSULE | EJJ | Substantially Equivalent | |
| K780966 | LEE-ALLOY DISPOSABLE CAPSULES | DZS | Substantially Equivalent | |
| K780967 | LEE-ALLOY | EJJ | Substantially Equivalent | |
| K780965 | NEW RESTODENT | EBF | Substantially Equivalent | |
| K772126 | TEMP. BRIDGE, POSTERIOR 3-UNIT | DYH | Substantially Equivalent | |
| K771077 | ULTRAVIOLET RAD-EMITTING LAMP | EBZ | Substantially Equivalent | |
| K771076 | ORTHODONTIC BRACKET ADHESIVE | DYH | Substantially Equivalent | |
| K770109 | ENAMELITE ENAMEL COATING | EBF | Substantially Equivalent | |
| K770055 | COMPOSITE RESTORATIVE MATERIAL, PRESTIGE | EBF | Substantially Equivalent | |
| K760419 | ADHESION PROMOTOR | EBD | Substantially Equivalent | |
| K760418 | 9075 | EBC | Substantially Equivalent | |
| K760417 | LEE-FILL ULTRAVIOLET-CURED REST. MAT. | EBF | Substantially Equivalent | |
| K760324 | BONDING AGENT, PRESTIGE | KLE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- EBZActivator, Ultraviolet, For Polymerization
- DYHAdhesive, Bracket And Tooth Conditioner, Resin
- KLEAgent, Tooth Bonding, Resin
- EJJAlloy, Amalgam
- DYWBracket, Plastic, Orthodontic
- DZSCapsule, Dental, Amalgam
- EBDCoating, Filling Material, Resin
- EBFMaterial, Tooth Shade, Resin
- KIFResin, Root Canal Filling
- EBCSealant, Pit And Fissure, And Conditioner
- EIDSyringe, Restorative And Impression Material
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain