Cleared Traditional

K043226 - ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K043226 · Imtec Corp. · Dental device
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Jan 2005
Decision
52d
Days
Class 2
Risk

K043226 is an FDA 510(k) clearance for the ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Imtec Corp. (Ardmore, US). The FDA issued a Cleared decision on January 13, 2005 after a review of 52 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 Imtec Corp. devices

Submission Details

510(k) Number K043226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2004
Decision Date January 13, 2005
Days to Decision 52 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 127d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 1541
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