Cleared Traditional

K151391 - BTI Dental Implant System UnicCa

K151391 is an FDA 510(k) clearance for BTI Dental Implant System UnicCa, manufactured by B.T.I. Biotechnology Institute, Sl.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 342-day FDA review.

K151391 · B.T.I. Biotechnology Institute, Sl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
342d
Days
Class 2
Risk

K151391 is an FDA 510(k) clearance for the BTI Dental Implant System UnicCa. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by B.T.I. Biotechnology Institute, Sl. (Minano, ES). The FDA issued a Cleared decision on May 2, 2016 after a review of 342 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 B.T.I. Biotechnology Institute, Sl. devices

FDA 510(k) Submission Details - K151391

510(k) Number K151391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2015
Decision Date May 02, 2016
Days to Decision 342 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
215d slower than avg
Panel avg: 127d · This submission: 342d
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 759
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K151391.
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OneQ-SL s-Clean Implant System
K153639 · Dentis Co., Ltd. · Apr 2016
Straumann Bone Level Tapered Implants
K153758 · Institut Straumann AG · Mar 2016