COMPOSITE RESTORATIVE MATERIAL, PRESTIGE— 510(k) K770055

Name: FDA 510(k) clearance K770055
Creator: U.S. Food and Drug Administration
Published: 1977-01-14

Substantially Equivalent

Lee Pharmaceuticals

FDA 510(k) clearance K770055 for COMPOSITE RESTORATIVE MATERIAL, PRESTIGE, Substantially Equivalent on 1977-01-14. 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: 1977-01-11
Decision date: 1977-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

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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

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K900809 — LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS1990-06-28
K894315 — RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT1989-10-31
K881903 — PROSTHODENT VL1988-07-01

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