Cleared Traditional

K781045 - A-33 DENTAL ALLOY

K781045 is an FDA 510(k) clearance for A-33 DENTAL ALLOY, manufactured by Howmedica Corp.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K781045 · Howmedica Corp. · Dental device
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Jul 1978
Decision
36d
Days
Class 2
Risk

K781045 is an FDA 510(k) clearance for the A-33 DENTAL ALLOY. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1978 after a review of 36 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K781045

510(k) Number K781045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1978
Decision Date July 27, 1978
Days to Decision 36 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
91d faster than avg
Panel avg: 127d · This submission: 36d
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 551
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K781045.
GDC-591
K790006 · Deringer-Ney, Inc. · Feb 1979
GOLD, 24 KARAT CASTING
K781788 · Williams Gold Refining Co., Inc. · Dec 1978
IMAGE
K781169 · Deringer-Ney, Inc. · Aug 1978
COLOR COTE
K771863 · Williams Gold Refining Co., Inc. · Oct 1977
HERITAGE SPECIAL ALLOY
K771110 · Howmedica Corp. · Jul 1977
BIOBOND C&B POST SOLDER
K770009 · Dentsply Intl. · Jan 1977