Dental Device Guide
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Manufacturer registered with FDA

Geistlich Pharma AG

WOLHUSEN, Switzerland. Lists 2 dental device types with FDA across 1 registered establishment, and holds 30 510(k) clearances as applicant.

FDA owner/operator9011644Manufacturer8 clearances in five years
Device types listed
2
Brands and models
21
510(k) clearances
301987–2025
Markets registered in
16204 registrations outside the US
Establishments
1Switzerland
1987: 21992: 11995: 31997: 11998: 32000: 12002: 12004: 12011: 22012: 12013: 12014: 12017: 22019: 12021: 12022: 12024: 12025: 619801990200020102020

510(k) clearances per year, 1980–2026

Registered in 16 markets

Where regulators' registries name Geistlich Pharma AG as the manufacturer or the registration holder of a device.

All markets
United States: 2 device types listedColombia: 60 registrationsCanada: 28 registrationsAustralia: 15 registrationsBrazil: 12 registrationsSouth Korea: 11 registrationsIsrael: 10 registrationsTaiwan: 10 registrationsCosta Rica: 9 registrationsSaudi Arabia: 9 registrationsUnited Kingdom: 9 registrationsHong Kong: 8 registrationsEgypt: 7 registrationsSerbia: 7 registrationsChina: 5 registrationsPeru: 4 registrations
RegisteredHome: SwitzerlandOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerGeistlich Pharma AG30 clearances1987–2025Below
ColombiaINVIMARegistration holderGEISTLICH PHARMA AG.GEISTLICH PHARMA AG60—Pure Global AI
CanadaHealth CanadaRegistration holderGEISTLICH PHARMA AG281999–2026Pure Global AI
AustraliaTGAManufacturerGeistlich Pharma AG152007–2026Pure Global AI
BrazilANVISAManufacturerGEISTLICH PHARMA AG122013–2020Pure Global AI
South KoreaMFDSManufacturerGeistlich Pharma AGGeistlich Pharma Ag111998–2023Pure Global AI
IsraelAMARManufacturerGeistlich Pharma AG10—Pure Global AI
TaiwanTFDAManufacturerGEISTLICH PHARMA AGGeistlich Pharma AG102006–2026Pure Global AI
Costa RicaMinisterio de SaludManufacturerGeistlich Pharma AG9—Pure Global AI
Saudi ArabiaSFDAManufacturerGeistlich Pharma AG9—Pure Global AI
United KingdomMHRAManufacturerGeistlich Pharma AG9—Pure Global AI
Hong KongMDDManufacturerGeistlich Pharma AG82026–2026Pure Global AI
EgyptEDAManufacturerGeistlich Pharma AG,72024–2026Pure Global AI
SerbiaALIMSManufacturerGeistlich Pharma AG72022–2024Pure Global AI
ChinaNMPARegistration holder瑞士盖氏制药有限公司Geistlich Pharma AG5—Pure Global AI
PeruDIGEMIDManufacturerGEISTLICH PHARMA AG42012–2025Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Geistlich Pharma AG currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Animal Source Bone Grafting MaterialNPM · Class 2Bone grafts & membranesMaker
Combi-Kit CollagenGeistlich Bio-Gide®Geistlich Bio-Gide® CompressedGeistlich Bio-Gide® ForteGeistlich Bio-Gide® PerioGeistlich Bio-Gide® ShapeGeistlich Bio-OssGeistlich Bio-Oss BlockGeistlich Bio-Oss CollagenGeistlich Bio-Oss Flow
4 more
Geistlich Bio-Oss PenGeistlich Combi-Kit CollagenGeistlich Perio-System Combi PackPerio-System Combi Pack
2014
Intraoral Animal Source BarrierNPL · Class 2Bone grafts & membranesMaker
Geistlich Bio-Gide®Geistlich Bio-Gide® CompressedGeistlich Bio-Gide® ForteGeistlich Bio-Gide® PerioGeistlich Bio-Gide® ShapeGeistlich Combi-Kit CollagenGeistlich Perio-System Combi Pack
2021

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Geistlich Pharma AG as the applicant.

Decided510(k)DeviceDevice type
25 Nov 2025K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®NPL Intraoral Animal Source Barrier
14 Aug 2025K251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi PackNPL Intraoral Animal Source Barrier
11 Jul 2025K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®NPM Animal Source Bone Grafting Material
26 Jun 2025K251613SwissGraft XNPM Animal Source Bone Grafting Material
15 Apr 2025K250833SwissMembrane X; SwissMembrane X SocketNPL Intraoral Animal Source Barrier
7 Mar 2025K242510Geistlich Bio-Flow®NPM Animal Source Bone Grafting Material
12 Jul 2024K240661Geistlich Bio-Oss®NPM Animal Source Bone Grafting Material
5 Apr 2022K212463Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi PackNPL Intraoral Animal Source Barrier
3 Mar 2021K210280Geistlich Mucograft®, Geistlich Mucograft® SealNPL Intraoral Animal Source Barrier
29 Aug 2019K192042Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft SealNPL Intraoral Animal Source Barrier
9 Nov 2017K171050Geistlich Fibro-GideNPL Intraoral Animal Source Barrier
30 Oct 2017K171643Geistlich Bio-Gide Shape, Geistlich Bio-Gide CompressedNPL Intraoral Animal Source Barrier
18 Jul 2014K140518GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETERNPL Intraoral Animal Source Barrier
15 Feb 2013K122894GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLICNPM Animal Source Bone Grafting Material
24 May 2012K120601GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-ONPM Animal Source Bone Grafting Material
28 Dec 2011K112572GEISTLICH COMBI-KIT COLLEGENNPM Animal Source Bone Grafting Material
27 Dec 2011K112575GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIONPM Animal Source Bone Grafting Material
15 Jan 2004K033815BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGENNPM Animal Source Bone Grafting Material
28 Mar 2002K014289ORTHOSS RESORBABLE BONE VOID FILLERLYC Synthetic Bone Grafting Material
14 Aug 2000K970569BIO-BLOCKSLYC Synthetic Bone Grafting Material
16 Sep 1998K974399BIO-OSS COLLAGENLYC Synthetic Bone Grafting Material
15 Sep 1998K970321BIO-OSS ANORGANIC BOVINE BONELYC Synthetic Bone Grafting Material
24 Jul 1998K972817RESOR-PIN RESORBABLE MEMBRANE PINLYC Synthetic Bone Grafting Material
11 Jun 1997K960724BIO-GIDE RESORBABLE BILAYER MEMBRANENPK Intraoral Synthetic Barrier
28 Aug 1995K952619BIO-OSS CERAMICLYC Synthetic Bone Grafting Material
28 Aug 1995K952618BIO-OSSLYC Synthetic Bone Grafting Material
7 Aug 1995K952617BIO-OSSLYC Synthetic Bone Grafting Material
24 Nov 1992K920508BIO-OSS BLOCKSLYC Synthetic Bone Grafting Material
8 Dec 1987K873763BIO-OSS - CERAMIC PURE NATURAL HYDROXYAPATITELYC Synthetic Bone Grafting Material
24 Aug 1987K871773BIO-OSS PURE NAT HYDROXYAPATITE ENDOSS IMPLANTLYC Synthetic Bone Grafting Material

Registered establishments

EstablishmentLocationWhat it does
GEISTLICH PHARMA AGFDA reg. 9614442WOLHUSEN Luzern, SwitzerlandComplaint file establishment, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9011644). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.