Cleared Traditional

K771749 - AMALGAM DISPENSER (FDA 510(k) Clearance)

Class I Dental device.

K771749 · New Dimensions IN Medicine, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1977
Decision
13d
Days
Class 1
Risk

K771749 is an FDA 510(k) clearance for the AMALGAM DISPENSER. Classified as Dispenser, Mercury And/or Alloy (product code EHE), Class I - General Controls.

Submitted by New Dimensions IN Medicine, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 28, 1977 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3080 - 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 New Dimensions IN Medicine, Inc. devices

Submission Details

510(k) Number K771749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1977
Decision Date September 28, 1977
Days to Decision 13 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 127d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EHE Dispenser, Mercury And/or Alloy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3080
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.