Cleared Traditional

K960899 - IMCOR 5.00 MM HEX SELF-TAPPING SCREW W/COVER SCREW

K960899 is an FDA 510(k) clearance for IMCOR 5.00 MM HEX SELF-TAPPING SCREW W/..., manufactured by Imcor. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K960899 · Imcor · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
104d
Days
Class 2
Risk

K960899 is an FDA 510(k) clearance for the IMCOR 5.00 MM HEX SELF-TAPPING SCREW W/COVER SCREW. 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 June 17, 1996 after a review of 104 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.

FDA 510(k) Submission Details - K960899

510(k) Number K960899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1996
Decision Date June 17, 1996
Days to Decision 104 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 128d · This submission: 104d
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 1500
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K960899.
CERA ONE ABUTMENT SYSTEM
K961737 · Nobelpharma USA, Inc. · Jul 1996
LAMINOSS DENTAL IMPLANT
K933705 · Impladent , Ltd. · Jun 1996
TITANIUM HEALING CAPS
K960634 · The Straumann Co. · Jun 1996
ACE SREW DENTLA IMPLANT SYSTEM
K954513 · Ace Surgical Supply Co., Inc. · Jun 1996
ACE CYLINDER DENTAL IMPLANT
K954605 · Ace Surgical Supply Co., Inc. · Jun 1996
IMCOR 3.75 MM WIDE HEX SELF-TAPPING SCREW W/COVER SCREW
K960900 · Imcor · Jun 1996
K960899 · IMCOR 5.00 MM HEX SELF-TAPPING SCREW W/COVER SCREW
Download PDF FDA Summary Imcor