RESO-PAC PERIODONTAL DRESSING— 510(k) K050658

Name: FDA 510(k) clearance K050658
Creator: U.S. Food and Drug Administration
Published: 2005-05-27

Substantially Equivalent

Hager Worldwide, Inc.

FDA 510(k) clearance K050658 for RESO-PAC PERIODONTAL DRESSING, Substantially Equivalent on 2005-05-27. Applicant: Hager Worldwide, Inc.. Device class: 2.

Clearance details

Applicant: Hager Worldwide, Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2005-03-14
Decision date: 2005-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EMA

view all

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 Hager Worldwide, Inc.

view all

K061933 — HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER2006-11-16
K043322 — MIRAMATIC SAFE SYRINGE SYSTEM2005-07-21

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