Cleared Traditional

K790874 - AMALCAP-NON-GAMMA-2

K790874 is an FDA 510(k) clearance for AMALCAP-NON-GAMMA-2, manufactured by Vivadent (Usa), Inc.. The device is a Class 2 Dental device with product code EJJ cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K790874 · Vivadent (Usa), Inc. · Dental device
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Jun 1979
Decision
29d
Days
Class 2
Risk

K790874 is an FDA 510(k) clearance for the AMALCAP-NON-GAMMA-2. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by Vivadent (Usa), Inc. (Mchenry, US). The FDA issued a Cleared decision on June 5, 1979 after a review of 29 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 Vivadent (Usa), Inc. devices

FDA 510(k) Submission Details - K790874

510(k) Number K790874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1979
Decision Date June 05, 1979
Days to Decision 29 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
98d faster than avg
Panel avg: 127d · This submission: 29d
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 45
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K790874.
ORBIC* SPHERICAL ALLOY
K812827 · Johnson & Johnson Professionals, Inc. · Nov 1981
PERMITE DENTAL AMALGAM ALLOY
K801639 · Southern Dental Industries, Inc. · Aug 1980
VALIANT
K801690 · L.D. Caulk Co. · Aug 1980
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