Cleared Traditional

BTI Dental Implant System UnicCa (K173257) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173257 · B.T.I. Biotechnology Institute, Sl. · Dental device
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Aug 2018
Decision
311d
Days
Class 2
Risk

K173257 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 August 17, 2018 after a review of 311 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

Submission Details

510(k) Number K173257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2017
Decision Date August 17, 2018
Days to Decision 311 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
184d slower than avg
Panel avg: 127d · This submission: 311d
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 304
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K173257.
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OsteoReady Dental Implant System
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K173819 · Hager& Meisinger GmbH · Aug 2018
UNIQA Dental Implants System
K180598 · Uniqa Dental, Ltd. · Aug 2018