Cleared Traditional

K915507 - E-Z GOLD TOOTH FILLING MATERIAL

K915507 is an FDA 510(k) clearance for E-Z GOLD TOOTH FILLING MATERIAL, manufactured by Lloyd Baum Center, Inc.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K915507 · Lloyd Baum Center, Inc. · Dental device
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May 1992
Decision
148d
Days
Class 2
Risk

K915507 is an FDA 510(k) clearance for the E-Z GOLD TOOTH FILLING MATERIAL. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Lloyd Baum Center, Inc. (Loma Linda, US). The FDA issued a Cleared decision on May 5, 1992 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Lloyd Baum Center, Inc. devices

FDA 510(k) Submission Details - K915507

510(k) Number K915507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1991
Decision Date May 05, 1992
Days to Decision 148 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 127d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJT Device Classification - Class 2, Special Controls

Product Code EJT Alloy, Gold-based Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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 - EJT Alloy, Gold-based Noble Metal

All 552
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K915507.
ARGENCO 75M
K924241 · Argen Precious Metals, Inc. · Nov 1992
BIOLOR
K921772 · Degussa AG · Jul 1992
CERADELTA 2
K921794 · Metalor Dental USA Corp. · Jul 1992
DENTAL SOLDER ALLOY
K920060 · Deringer-Ney, Inc. · Apr 1992
DW240 #73C ALLOY FOR PORCELAIN FUSED TO METAL
K920244 · Ivoclar North America, Inc. · Mar 1992
EZ GOLD
K915626 · Ivoclar North America, Inc. · Feb 1992