Cleared Traditional

K902911 - TITANIUM/STAINLESS STEEL INSTRUMENTS

K902911 is an FDA 510(k) clearance for TITANIUM/STAINLESS STEEL INSTRUMENTS, manufactured by Impla-Med. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K902911 · Impla-Med · Dental device
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Sep 1990
Decision
66d
Days
Class 2
Risk

K902911 is an FDA 510(k) clearance for the TITANIUM/STAINLESS STEEL INSTRUMENTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Impla-Med (Sunrise, US). The FDA issued a Cleared decision on September 6, 1990 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 Impla-Med devices

FDA 510(k) Submission Details - K902911

510(k) Number K902911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1990
Decision Date September 06, 1990
Days to Decision 66 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 127d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 1322
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K902911.
AIB-1120 ANALOG-IMPLANT BODY
K903517 · Minimatic Implant Technology · Nov 1990
SWEDE-VENT ENDOSSEOUS IMPLANT ABUTMENTS
K900182 · Core-Vent Corp. · Nov 1990
SWEDE-VENT ENDOSSEOUS HA COATED DENTAL IMPLANTS
K900634 · Core-Vent Corp. · Nov 1990
INTERPORE IMZ SINGLE TOOTH ATTACHMENT SYSTEM
K900793 · Interpore Intl. · Jul 1990
CORE-VENT ARMENTARIUM
K900177 · Core-Vent Corp. · Jun 1990
INTEGRAL PLUS BIOINTEGRATED DENTAL IMPLANT SYSTEM
K900549 · Calcitek, Inc. · Jun 1990