Dental Device Guide
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Manufacturer registered with FDA

Hans Biomed Corp.

Daejeon, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator9054234Manufacturer
Device types listed
1
Brands and models
2
510(k) clearances
12014–2014
Markets registered in
15171 registrations outside the US
Establishments
1South Korea
2014: 120102020

510(k) clearances per year, 2007–2026

Registered in 15 markets

Where regulators' registries name Hans Biomed Corp. as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedColombia: 61 registrationsTaiwan: 27 registrationsCanada: 14 registrationsEuropean Union: 14 registrationsCosta Rica: 12 registrationsSaudi Arabia: 11 registrationsBrazil: 8 registrationsChina: 7 registrationsPhilippines: 6 registrationsPeru: 5 registrationsAustralia: 3 registrationsHong Kong: 1 registrationsIsrael: 1 registrationsUnited Kingdom: 1 registrations
RegisteredHome: South KoreaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerHans Biomed Corp.1 clearances2014–2014Below
ColombiaINVIMARegistration holderHANSBIOMED CORPHANS BIOMED CORP · HANSBIOMED CORP. · +161—Pure Global AI
TaiwanTFDAManufacturerHANS BIOMED CORP.HansBiomed Corp. · HANS BIOMED CORPORATION · +1272006–2026Pure Global AI
CanadaHealth CanadaRegistration holderHANSBIOMED CORP.142013–2025Pure Global AI
European UnionEUDAMEDManufacturerHans Biomed Corp.HANS BIOMED S.L.14—Pure Global AI
Costa RicaMinisterio de SaludManufacturerHansBiomed Corp.HANS BIOMED CORP.12—Pure Global AI
Saudi ArabiaSFDAManufacturerHans Biomed CorporationHansBiomed Corp. · HANS BIOMED CORP11—Pure Global AI
BrazilANVISAManufacturerHANSBIOMED CORP.HANSBIOMED CO., LTD.82015–2024Pure Global AI
ChinaNMPARegistration holder韩士生科公司HansBiomed Corp.Hans Biomed Corp. 韩士生科公司 · 韩士生科公司 Hans Biomed Corp. · +17—Pure Global AI
PhilippinesFDA PhilippinesManufacturerHansBiomed Corp.62025–2025Pure Global AI
PeruDIGEMIDManufacturerHANSBIOMED CORP.HANS BIOMED CORP.52019–2025Pure Global AI
AustraliaTGAManufacturerHansBiomed Corp32019–2019Pure Global AI
Hong KongMDDManufacturerHansBiomed Corp.12020–2020Pure Global AI
IsraelAMARManufacturerHANS BIOMED CORP.1—Pure Global AI
United KingdomMHRAManufacturerHansBiomed Corp.1—Pure 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 Hans Biomed Corp. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Human Source Bone Grafting MaterialNUN · Class 2Bone grafts & membranesMaker
ExFuse(tm) II PuttySurFuse(tm) II Putty
2014

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 Hans Biomed Corp. as the applicant.

Decided510(k)DeviceDevice type
10 Jan 2014K130235SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTYNUN Human Source Bone Grafting Material

Registered establishments

EstablishmentLocationWhat it does
HANS BIOMED CORP.FDA reg. 3003828812Daejeon, South KoreaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9054234). 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.