Cleared Traditional

K912262 - HEXLOCK

K912262 is the FDA 510(k) clearance for HEXLOCK by Imtec Corp.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K912262 · Imtec Corp. · Dental device
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Dec 1991
Decision
202d
Days
Class 2
Risk

K912262 is an FDA 510(k) clearance for the HEXLOCK. 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 December 10, 1991 after a review of 202 days - an extended review 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: 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 Imtec Corp. devices

Submission Details

510(k) Number K912262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1991
Decision Date December 10, 1991
Days to Decision 202 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
75d slower than avg
Panel avg: 127d · This submission: 202d
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 698
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K912262.
STERI-OSS DRILLS AND TAPS
K915733 · Steri-Oss, Inc. · Jul 1992
DPI-1106 IMPLANT, MODIFICATION
K911776 · Minimatic Implant Technology · Jan 1992
BRANEMARK SYSTEM-3.0MM FIXTURE
K911960 · Nobelpharma USA, Inc. · Dec 1991
VIDENT IMPAC IMPLANT ACCESSORIES
K904391 · Vident · Dec 1991
NOBELPHARMA CERAONE ABUTMENT SYSTEM
K910611 · Nobelpharma USA, Inc. · Aug 1991
BRANEMARK SYSTEM-5.0MM FIXTURE
K911961 · Nobelpharma USA, Inc. · Jul 1991