BIO-C SEALER— 510(k) K172701

Name: FDA 510(k) clearance K172701
Creator: U.S. Food and Drug Administration
Published: 2018-01-04

Substantially Equivalent

Angelus Industria DE Produtos Odontologicos S/A

FDA 510(k) clearance K172701 for BIO-C SEALER, Substantially Equivalent on 2018-01-04. Applicant: Angelus Industria DE Produtos Odontologicos S/A. Device class: 2.

Clearance details

Applicant: Angelus Industria DE Produtos Odontologicos S/A
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2017-09-07
Decision date: 2018-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Londrina, BR

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIF

view all

K262050 — Vioseal X2026-09-11
K253909 — NeoPEX Pre-Mixed Obturation Paste2026-09-04
K261514 — Calcium Hydroxide Temporary Filling Material (KP-Cal)2026-08-25
K261415 — Injectable Root Canal Sealer (KP-Root SP)2026-06-29
K253167 — Any-Paste2026-01-12

More clearances from Angelus Industria DE Produtos Odontologicos S/A

view all

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