Cleared Traditional

K780997 - AMALGAM ALLOY

K780997 is an FDA 510(k) clearance for AMALGAM ALLOY, manufactured by Syntex Corp.. The device is a Class 2 Dental device with product code EJJ cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K780997 · Syntex Corp. · Dental device
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Jul 1978
Decision
43d
Days
Class 2
Risk

K780997 is an FDA 510(k) clearance for the AMALGAM ALLOY. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by Syntex Corp. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1978 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3070 - 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 Syntex Corp. devices

FDA 510(k) Submission Details - K780997

510(k) Number K780997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1978
Decision Date July 27, 1978
Days to Decision 43 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 127d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJJ Device Classification - Class 2, Special Controls

Product Code EJJ Alloy, Amalgam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3070
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 - EJJ Alloy, Amalgam

All 46
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K780997.
VALIANT
K801690 · L.D. Caulk Co. · Aug 1980
AMALCAP-NON-GAMMA-2
K790874 · Vivadent (Usa), Inc. · Jun 1979
ALLOY, AMALGAM, DISP. CAPSULE
K781242 · Lee Pharmaceuticals · Aug 1978
LEE-ALLOY
K780967 · Lee Pharmaceuticals · Jun 1978
EASE (MODIFICATION TO)
K771403 · L.D. Caulk Co. · Aug 1977
ALLOY DISPOS-A-CAP DENTAL SCHOOL CAP
K771383 · Johnson & Johnson Professionals, Inc. · Aug 1977