Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lee Pharmaceuticals — Predicate Candidate Screening
29 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
127 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924378 | RESTOBOND 4 | Lee Pharmaceuticals | 1993-03-31 | 212 | 0 |
| K912256 | PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT | Lee Pharmaceuticals | 1991-07-24 | 63 | 0 |
| K900809 | LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS | Lee Pharmaceuticals | 1990-06-28 | 127 | 0 |
| K894315 | RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT | Lee Pharmaceuticals | 1989-10-31 | 109 | 0 |
| K881903 | PROSTHODENT VL | Lee Pharmaceuticals | 1988-07-01 | 56 | 0 |
| K873123 | LEE COMPOSITE INLAY SYSTEM | Lee Pharmaceuticals | 1988-01-20 | 163 | 0 |
| K863157 | RESTODENT POSTERIOR | Lee Pharmaceuticals | 1986-09-25 | 41 | 0 |
| K854882 | PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT | Lee Pharmaceuticals | 1986-01-30 | 55 | 0 |
| K844134 | CLEANSE N BOND II | Lee Pharmaceuticals | 1985-01-04 | 73 | 0 |
| K844133 | CLEANSE N BOND I | Lee Pharmaceuticals | 1985-01-04 | 73 | 0 |
| K843363 | RESTODENT VL | Lee Pharmaceuticals | 1984-10-25 | 58 | 0 |
| K840726 | RESTODENT DENTIN BONDING AGENT | Lee Pharmaceuticals | 1984-06-27 | 127 | 0 |
| K810923 | LEE ENDOFILL, ROOT CANAL FILLING RESIN | Lee Pharmaceuticals | 1981-04-21 | 15 | 0 |
| K810517 | INSTA-BOND | Lee Pharmaceuticals | 1981-03-24 | 27 | 0 |
| K781977 | APPLICATOR, LEE IMPRESSION | Lee Pharmaceuticals | 1978-12-20 | 23 | 0 |
| K781243 | MERCURY DISP. CAPSULE | Lee Pharmaceuticals | 1978-09-20 | 100 | 0 |
| K781242 | ALLOY, AMALGAM, DISP. CAPSULE | Lee Pharmaceuticals | 1978-08-21 | 70 | 0 |
| K780966 | LEE-ALLOY DISPOSABLE CAPSULES | Lee Pharmaceuticals | 1978-08-21 | 70 | 0 |
| K780967 | LEE-ALLOY | Lee Pharmaceuticals | 1978-06-22 | 10 | 0 |
| K780965 | NEW RESTODENT | Lee Pharmaceuticals | 1978-06-22 | 10 | 0 |
| K772126 | TEMP. BRIDGE, POSTERIOR 3-UNIT | Lee Pharmaceuticals | 1978-01-03 | 53 | 0 |
| K771076 | ORTHODONTIC BRACKET ADHESIVE | Lee Pharmaceuticals | 1977-06-24 | 9 | 0 |
| K771077 | ULTRAVIOLET RAD-EMITTING LAMP | Lee Pharmaceuticals | 1977-06-24 | 9 | 0 |
| K770109 | ENAMELITE ENAMEL COATING | Lee Pharmaceuticals | 1977-01-24 | 7 | 0 |
| K770055 | COMPOSITE RESTORATIVE MATERIAL, PRESTIGE | Lee Pharmaceuticals | 1977-01-14 | 3 | 0 |
| K760418 | 9075 | Lee Pharmaceuticals | 1976-08-23 | 14 | 0 |
| K760419 | ADHESION PROMOTOR | Lee Pharmaceuticals | 1976-08-23 | 14 | 0 |
| K760417 | LEE-FILL ULTRAVIOLET-CURED REST. MAT. | Lee Pharmaceuticals | 1976-08-23 | 14 | 0 |
| K760324 | BONDING AGENT, PRESTIGE | Lee Pharmaceuticals | 1976-08-03 | 8 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda