REGEN BIOCEMENT— 510(k) K063010

Substantially Equivalent

Steiner Laboratories

FDA 510(k) clearance K063010 for REGEN BIOCEMENT, Substantially Equivalent on 2006-11-28. Applicant: Steiner Laboratories. Device class: 2.

Clearance details

Applicant: Steiner Laboratories
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2006-10-02
Decision date: 2006-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kapolei, HI, 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

More clearances from Steiner Laboratories

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