Cleared Traditional

K931440 - CALCITEK TORQUE WRENCH SYSTEM

K931440 is the FDA 510(k) clearance for CALCITEK TORQUE WRENCH SYSTEM by Calcitek, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K931440 · Calcitek, Inc. · Dental device
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Jan 1994
Decision
310d
Days
Class 2
Risk

K931440 is an FDA 510(k) clearance for the CALCITEK TORQUE WRENCH SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Calcitek, Inc. (Carlsbad, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 310 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Calcitek, Inc. devices

Submission Details

510(k) Number K931440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1993
Decision Date January 26, 1994
Days to Decision 310 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
183d slower than avg
Panel avg: 127d · This submission: 310d
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 676
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K931440.
MINIBALL ABUTMENT
K930155 · Steri-Oss, Inc. · Feb 1994
BRANEMARK SYSTEM INTERLOCKING ABUTMENT/GOLD CYLIND
K925776 · Nobelpharma USA, Inc. · Feb 1994
HA-BIONTEGRATED DENTAL IMPLANT SYSTEMS
K914137 · Lifecore Biomedical, Inc. · Feb 1994
STERI-OSS TITANIUM SCREW SERIES IMPLANT
K923484 · Steri-Oss, Inc. · Dec 1993
STERI-OSS SCREW STYLE CP TITANIUM IMPLANT
K923695 · Steri-Oss, Inc. · Dec 1993
STERI-OSS SCREW STYLE ITIANIUM IMPLANT
K924121 · Steri-Oss, Inc. · Dec 1993