Cleared Traditional

K946311 - INTEGRAL VII 3.25MM BIOINTEGRATED DENTAL IMPLANT SYSTEM

K946311 is an FDA 510(k) clearance for INTEGRAL VII 3.25MM BIOINTEGRATED DENTA..., 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 280-day FDA review.

K946311 · Calcitek, Inc. · Dental device
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Oct 1995
Decision
280d
Days
Class 2
Risk

K946311 is an FDA 510(k) clearance for the INTEGRAL VII 3.25MM 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 October 4, 1995 after a review of 280 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 Calcitek, Inc. devices

FDA 510(k) Submission Details - K946311

510(k) Number K946311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1994
Decision Date October 04, 1995
Days to Decision 280 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
153d slower than avg
Panel avg: 127d · This submission: 280d
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 1287
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K946311.
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K953435 · Nobelpharma USA, Inc. · Oct 1995
3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS, MINIPLANTS (TM)
K950204 · Implant Innovations, Inc. · Sep 1995
BRANEMARK RESTORATIVE INSTRUMENT & COMPONENT TRAY
K953774 · Nobelpharma USA, Inc. · Sep 1995