Cleared Traditional

K931440 - CALCITEK TORQUE WRENCH SYSTEM

K931440 is an FDA 510(k) clearance for CALCITEK TORQUE WRENCH SYSTEM, manufactured by Calcitek, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K931440

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
Combination Product No
PCCP Authorized No
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.

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 1288
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K931440.
BRANEMARK SYSTEM INTERLOCKING ABUTMENT/GOLD CYLIND
K925776 · Nobelpharma USA, Inc. · Feb 1994
ASTRA TECH IMPLANTS-DENTAL SYSTEM
K931767 · Astra Tech, 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