SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE— 510(k) K011403

Name: FDA 510(k) clearance K011403
Creator: U.S. Food and Drug Administration
Published: 2001-09-11

Substantially Equivalent

Orthogen Corp.

FDA 510(k) clearance K011403 for SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE, Substantially Equivalent on 2001-09-11. Applicant: Orthogen Corp.. Device class: 2.

Clearance details

Applicant: Orthogen Corp.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2001-05-07
Decision date: 2001-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYC

view all

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.