Company ยท US
Lee Pharmaceuticals
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1993. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EBF | Material, Tooth Shade, Resin | 8 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 5 |
| KLE | Agent, Tooth Bonding, Resin | 5 |
| DZS | Capsule, Dental, Amalgam | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 2 |
| EJJ | Alloy, Amalgam | 2 |
| DYW | Bracket, Plastic, Orthodontic | 1 |
| 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 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 31, 1993 | K924378 | RESTOBOND 4 Lee Pharmaceuticals | KLE |
| Jul 24, 1991 | K912256 | PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT Lee Pharmaceuticals | KLE |
| Jun 28, 1990 | K900809 | LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS Lee Pharmaceuticals | DYW |
| Oct 31, 1989 | K894315 | RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT Lee Pharmaceuticals | KLE |
| Jul 1, 1988 | K881903 | PROSTHODENT VL Lee Pharmaceuticals | EBF |
| Jan 20, 1988 | K873123 | LEE COMPOSITE INLAY SYSTEM Lee Pharmaceuticals | EBF |
| Sep 25, 1986 | K863157 | RESTODENT POSTERIOR Lee Pharmaceuticals | EBF |
| Jan 30, 1986 | K854882 | PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT Lee Pharmaceuticals | EBC |
| Jan 4, 1985 | K844134 | CLEANSE N BOND II Lee Pharmaceuticals | DYH |
| Jan 4, 1985 | K844133 | CLEANSE N BOND I Lee Pharmaceuticals | DYH |
| Oct 25, 1984 | K843363 | RESTODENT VL Lee Pharmaceuticals | EBF |
| Jun 27, 1984 | K840726 | RESTODENT DENTIN BONDING AGENT Lee Pharmaceuticals | KLE |
| Apr 21, 1981 | K810923 | LEE ENDOFILL, ROOT CANAL FILLING RESIN Lee Pharmaceuticals | KIF |
| Mar 24, 1981 | K810517 | INSTA-BOND Lee Pharmaceuticals | DYH |
| Dec 20, 1978 | K781977 | APPLICATOR, LEE IMPRESSION Lee Pharmaceuticals | EID |
| Sep 20, 1978 | K781243 | MERCURY DISP. CAPSULE Lee Pharmaceuticals | DZS |
| Aug 21, 1978 | K781242 | ALLOY, AMALGAM, DISP. CAPSULE Lee Pharmaceuticals | EJJ |
| Aug 21, 1978 | K780966 | LEE-ALLOY DISPOSABLE CAPSULES Lee Pharmaceuticals | DZS |
| Jun 22, 1978 | K780967 | LEE-ALLOY Lee Pharmaceuticals | EJJ |
| Jun 22, 1978 | K780965 | NEW RESTODENT Lee Pharmaceuticals | EBF |
| Jan 3, 1978 | K772126 | TEMP. BRIDGE, POSTERIOR 3-UNIT Lee Pharmaceuticals | DYH |
| Jun 24, 1977 | K771077 | ULTRAVIOLET RAD-EMITTING LAMP Lee Pharmaceuticals | EBZ |
| Jun 24, 1977 | K771076 | ORTHODONTIC BRACKET ADHESIVE Lee Pharmaceuticals | DYH |
| Jan 24, 1977 | K770109 | ENAMELITE ENAMEL COATING Lee Pharmaceuticals | EBF |
| Jan 14, 1977 | K770055 | COMPOSITE RESTORATIVE MATERIAL, PRESTIGE Lee Pharmaceuticals | EBF |
| Aug 23, 1976 | K760419 | ADHESION PROMOTOR Lee Pharmaceuticals | EBD |
| Aug 23, 1976 | K760418 | 9075 Lee Pharmaceuticals | EBC |
| Aug 23, 1976 | K760417 | LEE-FILL ULTRAVIOLET-CURED REST. MAT. Lee Pharmaceuticals | EBF |
| Aug 3, 1976 | K760324 | BONDING AGENT, PRESTIGE Lee Pharmaceuticals | KLE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||