Cleared Traditional

K946319 - INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM

K946319 is an FDA 510(k) clearance for INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL..., 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 322-day FDA review.

K946319 · Calcitek, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
322d
Days
Class 2
Risk

K946319 is an FDA 510(k) clearance for the INTEGRAL VII 4.9MM 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 322 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 - K946319

510(k) Number K946319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1994
Decision Date November 15, 1995
Days to Decision 322 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
195d slower than avg
Panel avg: 127d · This submission: 322d
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 K946319.
RESTORE HA DENTAL IMPLANT SYSTEM
K954865 · Lifecore Biomedical, Inc. · Jan 1996
KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM
K955048 · The Implant Center of the Palm Beaches · Jan 1996
CAL-FORM DENTAL IMPLANTS
K933646 · Cal-Form, Inc. · Jan 1996
INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEM
K946345 · Calcitek, Inc. · Nov 1995
WIDE SCREWS TP-5B. PROS G5, TOOLS G5 OR 17-4 SS
K952985 · Implant Center of the Palm Beaches · Oct 1995
WIDE SCREW HA-5B, CYL-HA-5
K952991 · Implant Center of the Palm Beaches · Oct 1995