Cleared Traditional

K013383 - BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM

K013383 is an FDA 510(k) clearance for BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLA..., manufactured by Biomedical Implant Technology, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K013383 · Biomedical Implant Technology, Inc. · Dental device
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Jan 2002
Decision
90d
Days
Class 2
Risk

K013383 is an FDA 510(k) clearance for the BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Biomedical Implant Technology, Inc. (St. Catharines, On, CA). The FDA issued a Cleared decision on January 10, 2002 after a review of 90 days - within the typical 510(k) review window.

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 Biomedical Implant Technology, Inc. devices

FDA 510(k) Submission Details - K013383

510(k) Number K013383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2001
Decision Date January 10, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
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 985
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K013383.
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