Cleared Traditional

K973049 - IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM

K973049 is an FDA 510(k) clearance for IMCOR 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 90-day FDA review.

K973049 · Imcor · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
90d
Days
Class 2
Risk

K973049 is an FDA 510(k) clearance for the IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM. 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 November 13, 1997 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 872.3640 - 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: 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 Imcor devices

FDA 510(k) Submission Details - K973049

510(k) Number K973049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1997
Decision Date November 13, 1997
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 K973049.
SENDAX MDI (MINI DENTAL IMPLANT)
K972351 · Sendax Mdic Management, Inc. · Nov 1997
VARIABLE PARALLEL PIN
K973521 · Sulzer Calcitek, Inc. · Nov 1997
OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN 15 DEGREE AND 25 DEGREE INCLINATIONS. FOR IMPLANTS 3.3MM, 4
K972769 · Opti-Max · Nov 1997
BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM
K970499 · Nobel Biocare Uas, Inc. · Oct 1997
THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM
K972417 · Bicon, Inc. · Sep 1997
THE MAESTRO SYSTEM
K972313 · BioHorizons Implant Systems, Inc. · Sep 1997