Cleared Traditional

BTI Extra-Short Dental Implant System UnicCa (K202825) - FDA 510(k) Clearance

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

K202825 · B.T.I. Biotechnology Institute, Sl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
308d
Days
Class 2
Risk

K202825 is an FDA 510(k) clearance for the BTI Extra-Short 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 July 29, 2021 after a review of 308 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 K202825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2020
Decision Date July 29, 2021
Days to Decision 308 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
181d slower than avg
Panel avg: 127d · This submission: 308d
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 K202825.
AnyOne External Implant System
K203554 · Megagen Implant Co., Ltd. · Aug 2021
PrimeTaper EV Dental Implant
K210610 · Dentsply Sirona, Inc. · Aug 2021
Neodent Implant System - Zirconia Implant System
K210336 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Aug 2021
Straumann RidgeFit Implants
K211052 · Institut Straumann AG · Jul 2021
NUVO CF Implant System
K203309 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Jul 2021
S.I.N. Dental Implant System
K203725 · S.I.N. ? Sistema DE Implante Nacional S.A. · Jun 2021