Cleared Traditional

K941608 - INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING

K941608 is an FDA 510(k) clearance for INTEGRAL OMNILOC DENTAL IMPLANT WITH IN..., 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 399-day FDA review.

K941608 · Calcitek, Inc. · Dental device
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May 1995
Decision
399d
Days
Class 2
Risk

K941608 is an FDA 510(k) clearance for the INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING. 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 May 5, 1995 after a review of 399 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 - K941608

510(k) Number K941608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1994
Decision Date May 05, 1995
Days to Decision 399 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
272d slower than avg
Panel avg: 127d · This submission: 399d
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 K941608.
SURGICAL INSTRUMENT MOTOTRS AND ACCESSORIES/ATTACHMENTS
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OSTEOTOMES
K952193 · Steri-Oss, Inc. · Jun 1995
INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM
K944327 · Calcitek, Inc. · May 1995
BONE CUTTING INSTRUMENT AND ACCESSORIES
K950446 · Steri-Oss, Inc. · May 1995
KIS-II STR FIXTURES
K944725 · Implant Center of the Palm Beaches · Apr 1995
BONE CUTTING INSTRUMENT AND ACCESSORIES
K950936 · Steri-Oss, Inc. · Apr 1995