OSMED EPI-GUIDE— 510(k) K940643

Substantially Equivalent

Thm Biomedical, Inc.

FDA 510(k) clearance K940643 for OSMED EPI-GUIDE, Substantially Equivalent on 1996-10-15. Applicant: Thm Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Thm Biomedical, Inc.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 1994-02-14
Decision date: 1996-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Duluth, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYC

K253317 — Cytrans Elashield2026-07-06
K253883 — Bonalive Maxillofacial2026-05-14
K251818 — BONTREE PLUS2026-03-06
K244006 — FG Bone Graft M2025-09-17
K243745 — FG Bone Graft B2025-08-29

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