Cleared Traditional

BTI Interna Dental Implant System UnicCa - Prosthetic Components (K213106) - FDA 510(k) Clearance

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

K213106 · B.T.I. Biotechnology Institute, Sl. · Dental device
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Oct 2022
Decision
391d
Days
Class 2
Risk

K213106 is an FDA 510(k) clearance for the BTI Interna Dental Implant System UnicCa - Prosthetic Components. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by B.T.I. Biotechnology Institute, Sl. (Minano, ES). The FDA issued a Cleared decision on October 20, 2022 after a review of 391 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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 K213106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2021
Decision Date October 20, 2022
Days to Decision 391 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
264d slower than avg
Panel avg: 127d · This submission: 391d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 318
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K213106.
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K220823 · Preat Corporation · Oct 2022
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K222269 · Terrats Medical SL · Oct 2022
IPD Dental Implant Abutments
K222215 · Implant Protesis Dental 2004, S.L. · Oct 2022
A.B. Dental Devices Dental Implants System
K202144 · A.B. Dental Device , Ltd. · Sep 2022
Esthetic Abutments Nobel Biocare N1
K220339 · Nobel Biocare Services AG · Sep 2022
Dynamic TiBase
K221966 · Talladium Espana, SL · Sep 2022