THE Graft Collagen— 510(k) K230305

Substantially Equivalent

Purgo Biologics, Inc.

FDA 510(k) clearance K230305 for THE Graft Collagen, Substantially Equivalent on 2024-07-24. Applicant: Purgo Biologics, Inc.. Device class: 2.

Clearance details

Applicant: Purgo Biologics, Inc.
Product code: Code NPM
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2023-02-03
Decision date: 2024-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code NPM

K253723 — BOSS2026-06-16
K251786 — Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®2025-07-11
K251613 — SwissGraft X2025-06-26
K242510 — Geistlich Bio-Flow®2025-03-07
K240133 — Xenograft Bovine Bone Particulate2024-08-16

More clearances from Purgo Biologics, Inc.

K230091 — THE Cover2023-10-06
K222549 — OpenTex2023-05-11
K191737 — The Graft Bone Substitute2020-02-14
K180992 — Biotex2019-07-16
K173188 — The Graft Natural Bone Substitute2018-07-20

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