FREEPRINT temp— 510(k) K200273

Substantially Equivalent

Detax GmbH & Co. KG

FDA 510(k) clearance K200273 for FREEPRINT temp, Substantially Equivalent on 2020-10-27. Applicant: Detax GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Detax GmbH & Co. KG
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2020-02-04
Decision date: 2020-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ettlingen, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBG

K261261 — Dura-Arch2026-04-17
K253380 — FLNT Base and FLNT Temp2026-03-02
K251271 — TempFIT Temporary Crown and Bridge Resin2025-06-23
K243370 — DentaTOOTH2025-05-05
K243621 — Evoblock, Perléon2025-04-22

More clearances from Detax GmbH & Co. KG

K200461 — Freeprint denture2020-11-16
K162654 — mollosil plus2017-03-13
K100247 — DETAX IMPLANTLINK SEMI2010-07-23
K994012 — TEMPOFIT, MODEL 026932000-02-16

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