MD-FLEX HEAVY BODY— 510(k) K134008

Substantially Equivalent

Meta Biomed, Inc.

FDA 510(k) clearance K134008 for MD-FLEX HEAVY BODY, Substantially Equivalent on 2014-04-09. Applicant: Meta Biomed, Inc.. Device class: 2.

Clearance details

Applicant: Meta Biomed, Inc.
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2013-12-30
Decision date: 2014-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt. Airy, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ELW

K254142 — Dia-X Sil Heavy Body2026-09-16
K254152 — Dia-X Sil Light Body2026-09-16
K254112 — Dia-X Sil Bite2026-03-19
K253501 — Hydro Print Premium Fast Set - 454g (1lb) (052037) +9 more2025-10-31
K250969 — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST2025-06-27

More clearances from Meta Biomed, Inc.

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