Cleared Traditional

K770109 - ENAMELITE ENAMEL COATING

K770109 is an FDA 510(k) clearance for ENAMELITE ENAMEL COATING, manufactured by Lee Pharmaceuticals. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K770109 · Lee Pharmaceuticals · Dental device
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Jan 1977
Decision
7d
Days
Class 2
Risk

K770109 is an FDA 510(k) clearance for the ENAMELITE ENAMEL COATING. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Lee Pharmaceuticals (Mchenry, US). The FDA issued a Cleared decision on January 24, 1977 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lee Pharmaceuticals devices

FDA 510(k) Submission Details - K770109

510(k) Number K770109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1977
Decision Date January 24, 1977
Days to Decision 7 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 127d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 800
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K770109.
NIMETICAP
K771654 · Espe GmbH (Us) · Sep 1977
NUVA-FIL COMPOSITE RESTORATIVE (MODI.)
K771404 · L.D. Caulk Co. · Aug 1977
DENTAL RESTORATIVE IN CAPSULES
K770922 · Espe GmbH (Us) · Jun 1977
COMPOSITE RESTORATIVE MATERIAL, PRESTIGE
K770055 · Lee Pharmaceuticals · Jan 1977
FILLING, RESIN DENTAL (VYTOL)
K760377 · L.D. Caulk Co. · Aug 1976
LEE-FILL ULTRAVIOLET-CURED REST. MAT.
K760417 · Lee Pharmaceuticals · Aug 1976