Cleared Traditional

K901909 - SILAMAT (AMALGAMATOR)

K901909 is an FDA 510(k) clearance for SILAMAT (AMALGAMATOR), manufactured by Ivoclar North America, Inc.. The device is a Class 1 Dental device with product code EFD cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K901909 · Ivoclar North America, Inc. · Dental device
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Jun 1990
Decision
56d
Days
Class 1
Risk

K901909 is an FDA 510(k) clearance for the SILAMAT (AMALGAMATOR). Classified as Amalgamator, Dental, Ac-powered (product code EFD), Class I - General Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on June 22, 1990 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3100 - 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 Ivoclar North America, Inc. devices

FDA 510(k) Submission Details - K901909

510(k) Number K901909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1990
Decision Date June 22, 1990
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

EFD Device Classification - Class 1, General Controls

Product Code EFD Amalgamator, Dental, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3100
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.

Regulatory Peers - EFD Amalgamator, Dental, Ac-powered

All 9
Devices cleared under the same product code (EFD) and FDA review panel - the closest regulatory comparables to K901909.
DUOMAT 3 AMALGAMATOR
K914340 · Degussa AG · Nov 1991
MIXOMAT AMALGAMATOR
K914341 · Degussa AG · Nov 1991
DENTOMAT 3 AMALGAMATORS
K914339 · Degussa AG · Nov 1991
DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA.
K891612 · Implant Innovations International, Inc. · Jun 1989
ESPE CAPMIX
K891064 · Espe GmbH (Us) · May 1989
DENTAL AMALGAMATOR
K780560 · L.D. Caulk Co. · Apr 1978