Cleared Traditional

K912262 - HEXLOCK

K912262 is an FDA 510(k) clearance for HEXLOCK, manufactured by Imtec Corp.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K912262

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.

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 1300
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K912262.
DPI-1106 IMPLANT, MODIFICATION
K911776 · Minimatic Implant Technology · Jan 1992
INTERPORE HEX HEAD IMPLANT RESTORATIVE COMPONENTS
K912734 · Interpore Intl. · Jan 1992
BRANEMARK SYSTEM-3.0MM FIXTURE
K911960 · Nobelpharma USA, Inc. · Dec 1991
VIDENT IMPAC IMPLANT ACCESSORIES
K904391 · Vident · Dec 1991
TCAL ABUTMENT
K913782 · Core-Vent Corp. · Oct 1991
TSIR ANGLED ABUTMENTS
K910585 · Core-Vent Corp. · Oct 1991