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BTI Interna Narrow/Plus Dental Implant System UnicCa

by B.T.I. Biotechnology Institute, Sl.

510(k) K211952

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211952↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK211952 Date21 Jul 2022ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
DZE
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BTI Interna Narrow/Plus Dental Implant System UnicCa is a dental implant system designed for osseointegrated tooth replacement. It features internal hex connection implants, providing a stable foundation for single-tooth or multi-tooth restorations in the oral cavity, with variants for narrow and standard diameters to accommodate varying bone widths.

This system is supplied as a sterile, single-use device intended for surgical use by dental professionals. Implants are available in cobalt-chromium alloy (CrCo) construction, with sizes and configurations detailed in the specifications. Authorized under FDA 510(k) clearance and MDR compliance, it is intended for use in controlled clinical settings where dental implantology procedures are performed.

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