Cleared Traditional

K946345 - INTEGRAL VIII BIOINTEGRATED DENTAL IMPL...

K946345 is the FDA 510(k) clearance for INTEGRAL VIII BIOINTEGRATED DENTAL IMPL... by Calcitek, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 320-day FDA review.

K946345 · Calcitek, Inc. · Dental device
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Nov 1995
Decision
320d
Days
Class 2
Risk

K946345 is an FDA 510(k) clearance for the INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT 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 November 15, 1995 after a review of 320 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 K946345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1994
Decision Date November 15, 1995
Days to Decision 320 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
193d slower than avg
Panel avg: 127d · This submission: 320d
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 K946345.
BALL ATTACHMENT SYSTEM
K955372 · Nobelpharma USA, Inc. · Jan 1996
RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM
K954819 · Lifecore Biomedical, Inc. · Jan 1996
RESTORE HA DENTAL IMPLANT SYSTEM
K954865 · Lifecore Biomedical, Inc. · Jan 1996
STERI-OSS IMMEDIATE PLACEMENT IMPLANT
K952917 · Steri-Oss, Inc. · Oct 1995
BRANEMARK RADIOGRAPHIC DEPTH GUAGE
K953435 · Nobelpharma USA, Inc. · Oct 1995
3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLANTS (TM)
K950204 · Implant Innovations, Inc. · Sep 1995