Dental Device Guide
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Not currently registered with FDA under this name

Lee Pharmaceuticals

South El Monte, CA, United States. Named as applicant on 29 dental 510(k) clearances between 1976 and 1993. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
291976–1993
Markets registered in
1United States
Establishments
0—
1976: 41977: 41978: 71981: 21984: 21985: 21986: 21988: 21989: 11990: 11991: 11993: 119801990200020102020

510(k) clearances per year, 1976–2026

510(k) clearances

Clearances on which FDA names Lee Pharmaceuticals as the applicant.

Decided510(k)DeviceDevice type
31 Mar 1993K924378RESTOBOND 4KLE Resin Tooth Bonding Agent
24 Jul 1991K912256PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERTKLE Resin Tooth Bonding Agent
28 Jun 1990K900809LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETSDYW Orthodontic Plastic Bracket
31 Oct 1989K894315RESTOBOND 3/DENTIN-ENAMEL BONDING AGENTKLE Resin Tooth Bonding Agent
1 Jul 1988K881903PROSTHODENT VLEBF Resin Tooth Shade Material
20 Jan 1988K873123LEE COMPOSITE INLAY SYSTEMEBF Resin Tooth Shade Material
25 Sep 1986K863157RESTODENT POSTERIOREBF Resin Tooth Shade Material
30 Jan 1986K854882PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORATEBC Pit and Fissure Sealant and Conditioner
4 Jan 1985K844134CLEANSE N BOND IIDYH Resin Bracket and Tooth Conditioner Adhesive
4 Jan 1985K844133CLEANSE N BOND IDYH Resin Bracket and Tooth Conditioner Adhesive
25 Oct 1984K843363RESTODENT VLEBF Resin Tooth Shade Material
27 Jun 1984K840726RESTODENT DENTIN BONDING AGENTKLE Resin Tooth Bonding Agent
21 Apr 1981K810923LEE ENDOFILL, ROOT CANAL FILLING RESINKIF Root Canal Filling Resin
24 Mar 1981K810517INSTA-BONDDYH Resin Bracket and Tooth Conditioner Adhesive
20 Dec 1978K781977APPLICATOR, LEE IMPRESSIONEID Restorative and Impression Material Syringe
20 Sep 1978K781243MERCURY DISP. CAPSULEDZS Amalgam Dental Capsule
21 Aug 1978K781242ALLOY, AMALGAM, DISP. CAPSULEEJJ Amalgam Alloy
21 Aug 1978K780966LEE-ALLOY DISPOSABLE CAPSULESDZS Amalgam Dental Capsule
22 Jun 1978K780967LEE-ALLOYEJJ Amalgam Alloy
22 Jun 1978K780965NEW RESTODENTEBF Resin Tooth Shade Material
3 Jan 1978K772126TEMP. BRIDGE, POSTERIOR 3-UNITDYH Resin Bracket and Tooth Conditioner Adhesive
24 Jun 1977K771077ULTRAVIOLET RAD-EMITTING LAMPEBZ Ultraviolet Activator for Polymerization
24 Jun 1977K771076ORTHODONTIC BRACKET ADHESIVEDYH Resin Bracket and Tooth Conditioner Adhesive
24 Jan 1977K770109ENAMELITE ENAMEL COATINGEBF Resin Tooth Shade Material
14 Jan 1977K770055COMPOSITE RESTORATIVE MATERIAL, PRESTIGEEBF Resin Tooth Shade Material
23 Aug 1976K760419ADHESION PROMOTOREBD Resin Filling Material Coating
23 Aug 1976K7604189075EBC Pit and Fissure Sealant and Conditioner
23 Aug 1976K760417LEE-FILL ULTRAVIOLET-CURED REST. MAT.EBF Resin Tooth Shade Material
3 Aug 1976K760324BONDING AGENT, PRESTIGEKLE Resin Tooth Bonding Agent

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.