Cleared Traditional

K891519 - C-86 GOLD BASE DENTAL ALLOY

K891519 is an FDA 510(k) clearance for C-86 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 26-day FDA review.

K891519 · Macdonald Metals and Ceramics · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1989
Decision
26d
Days
Class 2
Risk

K891519 is an FDA 510(k) clearance for the C-86 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 12, 1989 after a review of 26 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 - K891519

510(k) Number K891519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1989
Decision Date April 12, 1989
Days to Decision 26 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
101d faster than avg
Panel avg: 127d · This submission: 26d
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 K891519.
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
C-76 GOLD BASE DENTAL ALLOY
K891518 · Macdonald Metals and Ceramics · Apr 1989
C-87 GOLD BASE DENTAL ALLOY
K891520 · Macdonald Metals and Ceramics · Apr 1989
M-1 GOLD BASE DENTAL ALLOY
K891521 · Macdonald Metals and Ceramics · Apr 1989
M-4 GOLD BASE DENTAL ALLOY
K891522 · Macdonald Metals and Ceramics · Apr 1989