DETAX IMPLANTLINK SEMI— 510(k) K100247

Substantially Equivalent

Detax GmbH & Co. KG

FDA 510(k) clearance K100247 for DETAX IMPLANTLINK SEMI, Substantially Equivalent on 2010-07-23. Applicant: Detax GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Detax GmbH & Co. KG
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2010-01-27
Decision date: 2010-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amsterdam, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code EMA

K254201 — Any-Cem2026-08-13
K261937 — PacTemp Automix NE2026-08-07
K261166 — DIA-CEM2026-07-09
K254109 — G-CEM UNIVERSAL2026-05-18
K253337 — REGEN Bioactive Cement2026-04-15

More clearances from Detax GmbH & Co. KG

K200461 — Freeprint denture2020-11-16
K200273 — FREEPRINT temp2020-10-27
K162654 — mollosil plus2017-03-13
K994012 — TEMPOFIT, MODEL 026932000-02-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.