Cleared Traditional

K932168 - HEXLOCK/HEXLOCK SCREW

K932168 is the FDA 510(k) clearance for HEXLOCK/HEXLOCK SCREW by Imtec Corp.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 476-day FDA review.

K932168 · Imtec Corp. · Dental device
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Aug 1994
Decision
476d
Days
Class 2
Risk

K932168 is an FDA 510(k) clearance for the HEXLOCK/HEXLOCK SCREW. 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 August 24, 1994 after a review of 476 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Imtec Corp. devices

Submission Details

510(k) Number K932168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1993
Decision Date August 24, 1994
Days to Decision 476 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
349d slower than avg
Panel avg: 127d · This submission: 476d
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 K932168.
LORENZ SURGICAL FINNED DENTAL IMPLANT
K941621 · Biomet, Inc. · Sep 1994
STERI-OSS TITANIUM PLASMA SPRAY SERIES IMPLANT
K925481 · Steri-Oss, Inc. · Sep 1994
STERI-OSS THREADED TPS HEX SERIES IMPLANT
K925555 · Steri-Oss, Inc. · Sep 1994
BRANEMARK SYSTEM DRILL CONTROLLER
K931785 · Nobelpharma USA, Inc. · Aug 1994
BRANEMARK SYSTEM
K934825 · Nobelpharma USA, Inc. · Aug 1994
BRANEMARK-HEALING CAPS, DCC045, DCC046, DCC104
K934826 · Nobelpharma USA, Inc. · Aug 1994