Lee Pharmaceuticals
Medical device manufacturer in South El Monte, CA.
29510(k) clearances
0PMA approvals
0recalls
Device types
- EBF Material, Tooth Shade, Resin 8
- KLE Agent, Tooth Bonding, Resin 5
- DYH Adhesive, Bracket And Tooth Conditioner… 5
- EBC Sealant, Pit And Fissure, And Conditioner 2
- EJJ Alloy, Amalgam 2
- DZS Capsule, Dental, Amalgam 2
- EBD Coating, Filling Material, Resin 1
- EBZ Activator, Ultraviolet, For Polymerization 1
- EID Syringe, Restorative And Impression Material 1
- KIF Resin, Root Canal Filling 1
- DYW Bracket, Plastic, Orthodontic 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K924378 | Restobond 4KLE · Traditional | 03/31/1993SE |
| K912256 | Precise(R) Beta Quartz Glass-Ceramic InsertKLE · Traditional | 07/24/1991SE |
| K900809 | Lee-Fischer Ceramic Reinforced Plastic BracketsDYW · Traditional | 06/28/1990SE |
| K894315 | Restobond 3/DENTIN-ENAMEL Bonding AgentKLE · Traditional | 10/31/1989SE |
| K881903 | Prosthodent VLEBF · Traditional | 07/01/1988SE |
| K873123 | Lee Composite Inlay SystemEBF · Traditional | 01/20/1988SE |
| K863157 | Restodent PosteriorEBF · Traditional | 09/25/1986SE |
| K854882 | Protec/Visible Light-Cured Sealant/Dental RestoratEBC · Traditional | 01/30/1986SE |
| K844134 | Cleanse N Bond IIDYH · Traditional | 01/04/1985SE |
| K844133 | Cleanse N Bond IDYH · Traditional | 01/04/1985SE |
| K843363 | Restodent VLEBF · Traditional | 10/25/1984SE |
| K840726 | Restodent Dentin Bonding AgentKLE · Traditional | 06/27/1984SE |
| K810923 | Lee Endofill, Root Canal Filling ResinKIF · Traditional | 04/21/1981SE |
| K810517 | Insta-BondDYH · Traditional | 03/24/1981SE |
| K781977 | Applicator, Lee ImpressionEID · Traditional | 12/20/1978SE |
| K781243 | Mercury Disp. CapsuleDZS · Traditional | 09/20/1978SE |
| K781242 | Alloy, Amalgam, Disp. CapsuleEJJ · Traditional | 08/21/1978SE |
| K780966 | Lee-Alloy Disposable CapsulesDZS · Traditional | 08/21/1978SE |
| K780967 | Lee-AlloyEJJ · Traditional | 06/22/1978SE |
| K780965 | New RestodentEBF · Traditional | 06/22/1978SE |
| K772126 | Temp. Bridge, Posterior 3-UNITDYH · Traditional | 01/03/1978SE |
| K771077 | Ultraviolet Rad-Emitting LampEBZ · Traditional | 06/24/1977SE |
| K771076 | Orthodontic Bracket AdhesiveDYH · Traditional | 06/24/1977SE |
| K770109 | Enamelite Enamel CoatingEBF · Traditional | 01/24/1977SE |
| K770055 | Composite Restorative Material, PrestigeEBF · Traditional | 01/14/1977SE |
| K760419 | Adhesion PromotorEBD · Traditional | 08/23/1976SE |
| K760418 | 9075EBC · Traditional | 08/23/1976SE |
| K760417 | Lee-Fill Ultraviolet-Cured Rest. Mat.EBF · Traditional | 08/23/1976SE |
| K760324 | Bonding Agent, PrestigeKLE · Traditional | 08/03/1976SE |