Cleared Traditional

K941608 - INTEGRAL OMNILOC DENTAL IMPLANT WITH IN...

K941608 is the FDA 510(k) clearance for INTEGRAL OMNILOC DENTAL IMPLANT WITH IN... by Calcitek, Inc.. It is a Class 2 Dental device (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

Submission Details

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
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.

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 K941608.
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K952448 · Nobelpharma USA, Inc. · Jun 1995
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K951065 · Steri-Oss, Inc. · Jun 1995
OSTEOTOMES
K952193 · Steri-Oss, Inc. · Jun 1995
BONE CUTTING INSTRUMENT AND ACCESSORIES
K950446 · Steri-Oss, Inc. · May 1995
BONE CUTTING INSTRUMENT AND ACCESSORIES
K950936 · Steri-Oss, Inc. · Apr 1995
STERI-OSS SCALER FOR DENTAL IMPLANTS
K943681 · Steri-Oss, Inc. · Apr 1995