Cleared Traditional

K974126 - IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, SELF TAPPING HA COATED SCREW IMPLANTS WITH COVER SCREW

K974126 is an FDA 510(k) clearance for IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, manufactured by Imcor. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K974126 · Imcor · Dental device
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Jan 1998
Decision
88d
Days
Class 2
Risk

K974126 is an FDA 510(k) clearance for the IMCOR 3.75 AND 5.00MM EXTERNALLY HEXED, SELF TAPPING HA COATED SCREW IMPLANTS.... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Imcor (Edina, US). The FDA issued a Cleared decision on January 30, 1998 after a review of 88 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 Imcor devices

FDA 510(k) Submission Details - K974126

510(k) Number K974126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1997
Decision Date January 30, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
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 940
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K974126.
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