GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC— 510(k) K122894

Name: FDA 510(k) clearance K122894
Creator: U.S. Food and Drug Administration
Published: 2013-02-15

Substantially Equivalent

Geistlich Pharma AG

FDA 510(k) clearance K122894 for GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC, Substantially Equivalent on 2013-02-15. Applicant: Geistlich Pharma AG. Device class: 2.

Clearance details

Applicant: Geistlich Pharma AG
Product code: Code NPM
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2012-09-20
Decision date: 2013-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NPM

view all

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 Geistlich Pharma AG

view all

K260364 — Device 300419 Strip2026-06-02
K260532 — Derma-Gide2026-03-19
K251323 — Device 104 Particulate2026-01-22
K252253 — Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®2025-11-25
K251062 — Geistlich Bio-Gide +6 more2025-08-14

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