Cleared Traditional

K760979 - COMPOSITE MATERIAL

K760979 is an FDA 510(k) clearance for COMPOSITE MATERIAL, manufactured by Adp Intl., Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K760979 · Adp Intl., Inc. · Dental device
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Nov 1976
Decision
25d
Days
Class 2
Risk

K760979 is an FDA 510(k) clearance for the COMPOSITE MATERIAL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Adp Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on November 15, 1976 after a review of 25 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 Adp Intl., Inc. devices

FDA 510(k) Submission Details - K760979

510(k) Number K760979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1976
Decision Date November 15, 1976
Days to Decision 25 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 128d · This submission: 25d
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 821
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K760979.
DENTAL RESTORATIVE IN CAPSULES
K770922 · Espe GmbH (Us) · Jun 1977
ENAMELITE ENAMEL COATING
K770109 · Lee Pharmaceuticals · Jan 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