Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614442

FEI Number

3000303710

Entity Name

GEISTLICH PHARMA AG

City/State/Country

WOLHUSEN Luzern, CH

Establishment Address

BAHNHOFSTRASSE 40, WOLHUSEN Luzern CH-6110, CH

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Geistlich Pharma AG (Owner Number: 9011644)

Owner / Operator Contact Address

BAHNHOFSTRASSE 40, --, WOLHUSEN, CH-LU CH-6110, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190754

PMA Number

N/A

All Registered Proprietary Names

Geistlich Fibro-Gide® Geistlich Bio-Oss Geistlich Bio-Oss Geistlich Bio-Oss Pen Derma-Gide® Geistlich Bio-Gide® Forte Geistlich Perio-System Combi Pack Geistlich Combi-Kit Collagen Geistlich Bio-Gide® Perio Geistlich Bio-Gide® Compressed Geistlich Bio-Gide® Shape Geistlich Bio-Gide®

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2025-06-30
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2017-11-10
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2024-08-07
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2024-08-07
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2026-02-20
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2021-03-12
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2025-07-14
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2025-12-10
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2018-11-16
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2025-08-20
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2025-08-20
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2026-04-13
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2019-07-01

Official Correspondent

No official correspondent registered.

US Agent Details

Pamela Hornickle Business: Director of Quality, Regulatory, and Compliance Email: Pamela.Hornickle@geistlich.com Phone: (267) 9189694

Related Public Records

Same Entity

Geistlich Pharma AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30
K173933	Xenco Medical, LLC	Sorrento Bioglass Bone Graft Substitute	2018-09-13
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614442. Last updated year: 2026. Please use registration number 9614442 when referencing this establishment in official correspondence.