Cleared Traditional

K891119 - T.R.S.: TOOTH REPLACEMENT SYSTEM

K891119 is an FDA 510(k) clearance for T.R.S.: TOOTH REPLACEMENT SYSTEM, manufactured by Health Technology of America, Inc.. The device is a Class 1 Dental device with product code EGG cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K891119 · Health Technology of America, Inc. · Dental device
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Apr 1989
Decision
46d
Days
Class 1
Risk

K891119 is an FDA 510(k) clearance for the T.R.S.: TOOTH REPLACEMENT SYSTEM. Classified as Attachment, Precision, All (product code EGG), Class I - General Controls.

Submitted by Health Technology of America, Inc. (New York, US). The FDA issued a Cleared decision on April 17, 1989 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3165 - 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 Health Technology of America, Inc. devices

FDA 510(k) Submission Details - K891119

510(k) Number K891119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1989
Decision Date April 17, 1989
Days to Decision 46 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 127d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

EGG Device Classification - Class 1, General Controls

Product Code EGG Attachment, Precision, All
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3165
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 - EGG Attachment, Precision, All

All 7
Devices cleared under the same product code (EGG) and FDA review panel - the closest regulatory comparables to K891119.
DENTAL CONNECTOR PRECISION ATTACHMENT
K912435 · Metalor Dental USA Corp. · Aug 1991
CONICAST, INTRACAST, OMECAST
K912567 · Metalor Dental USA Corp. · Jul 1991
INTERPORE IMZ(CASTABLE)TUB/SCRET RET RIGID ATTACH
K901928 · Interpore Intl. · Jul 1990
IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS
K870331 · Interpore Intl. · Mar 1987
DYNA SYSTEM
K855167 · Parker Laboratories, Inc. · Mar 1986
MICRO-RING SYSTEM PRECISION ATTACH.
K791788 · Howmedica Corp. · Oct 1979