ENAMELITE ENAMEL COATING— 510(k) K770109

Substantially Equivalent

Lee Pharmaceuticals

FDA 510(k) clearance K770109 for ENAMELITE ENAMEL COATING, Substantially Equivalent on 1977-01-24. Applicant: Lee Pharmaceuticals. Device class: 2.

Clearance details

Applicant: Lee Pharmaceuticals
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1977-01-17
Decision date: 1977-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

K262202 — Cerasmart Forte2026-09-10
K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)2026-08-31
K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

More clearances from Lee Pharmaceuticals

K924378 — RESTOBOND 41993-03-31
K912256 — PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT1991-07-24
K900809 — LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS1990-06-28
K894315 — RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT1989-10-31
K881903 — PROSTHODENT VL1988-07-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.