Cleared Traditional

K891516 - C-89 GOLD BASE DENTAL ALLOY

K891516 is an FDA 510(k) clearance for C-89 GOLD BASE DENTAL ALLOY, manufactured by Macdonald Metals and Ceramics. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K891516 · Macdonald Metals and Ceramics · Dental device
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Apr 1989
Decision
28d
Days
Class 2
Risk

K891516 is an FDA 510(k) clearance for the C-89 GOLD BASE DENTAL ALLOY. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Macdonald Metals and Ceramics (Santa Fe Springs, US). The FDA issued a Cleared decision on April 14, 1989 after a review of 28 days - a notably fast clearance cycle.

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: 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 Macdonald Metals and Ceramics devices

FDA 510(k) Submission Details - K891516

510(k) Number K891516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1989
Decision Date April 14, 1989
Days to Decision 28 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
99d faster than avg
Panel avg: 127d · This submission: 28d
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 548
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K891516.
ARGIPAL
K893011 · Argen Precious Metals, Inc. · May 1989
ARGEDENT 75
K892234 · Argen Precious Metals, Inc. · May 1989
ARGEDENT 52SF
K891911 · Argen Precious Metals, Inc. · May 1989
M-77 GOLD BASE DENTAL ALLOY
K891530 · Macdonald Metals and Ceramics · Apr 1989
C-5 PALLADIUM BASE DENTAL ALLOY
K891514 · Macdonald Metals and Ceramics · Apr 1989
C-63 GOLD BAE DENTAL ALLOY
K891517 · Macdonald Metals and Ceramics · Apr 1989