Cleared Traditional

K901928 - INTERPORE IMZ(CASTABLE)TUB/SCRET RET RI...

K901928 is an FDA 510(k) clearance for INTERPORE IMZ(CASTABLE)TUB/SCRET RET RI..., manufactured by Interpore Intl.. The device is a Class 1 Dental device with product code EGG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K901928 · Interpore Intl. · Dental device
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Jul 1990
Decision
90d
Days
Class 1
Risk

K901928 is an FDA 510(k) clearance for the INTERPORE IMZ(CASTABLE)TUB/SCRET RET RIGID ATTACH. Classified as Attachment, Precision, All (product code EGG), Class I - General Controls.

Submitted by Interpore Intl. (Rockville, US). The FDA issued a Cleared decision on July 26, 1990 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Interpore Intl. devices

FDA 510(k) Submission Details - K901928

510(k) Number K901928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1990
Decision Date July 26, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
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

Devices cleared under the same product code (EGG) and FDA review panel - the closest regulatory comparables to K901928.
DENTAL CONNECTOR PRECISION ATTACHMENT
K912435 · Metalor Dental USA Corp. · Aug 1991
CONICAST, INTRACAST, OMECAST
K912567 · Metalor Dental USA Corp. · Jul 1991
DYNA SYSTEM
K855167 · Parker Laboratories, Inc. · Mar 1986
MICRO-RING SYSTEM PRECISION ATTACH.
K791788 · Howmedica Corp. · Oct 1979
MICRO-RING
K780711 · Howmedica Corp. · May 1978