FDA Device Entity Profile: Nobel Biocare Services AG

Known Identifiers & Locations

FEI Numbers 1000125598, 3002807692, 3002807693, 3005031178, 3005739655, 3006540014, 3008693672

Owner Operator Numbers 8030879

Locations Covered GOTEBORG Vastra Gotaland, SE; KARLSKOGA Orebro, SE; Kloten Zurich, CH; MAHWAH, NJ, US; Mechelen Antwerpen, BE; Venlo Limburg, NL; YORBA LINDA, CA, US

Registration #	Establishment Name	Location	Establishment Type(s)	Action
2027971	NOBEL BIOCARE USA, LLC	YORBA LINDA, CA, US	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3005031178	NOBEL BIOCARE PROCERA, LLC	MAHWAH, NJ, US	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
3005739655	Nobel Biocare c/o Medicim NV	Mechelen Antwerpen, BE	Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device	View Details
3006540014	NOBEL BIOCARE DISTRIBUTION CENTER BV	Venlo Limburg, NL	Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device	View Details
3008693672	Nobel Biocare Services AG	Kloten Zurich, CH	Develop Specifications But Do Not Manufacture At This Facility	View Details
9611992	NOBEL BIOCARE AB	GOTEBORG Vastra Gotaland, SE	Develop Specifications But Do Not Manufacture At This Facility	View Details
9611993	NOBEL BIOCARE AB, PRODUKTION	KARLSKOGA Orebro, SE	Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details

No 510(k) notifications found for this entity.

No recall records found for this entity.

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Nobel Biocare Services AG

Known Identifiers & Locations

Registered Establishments (7)

510(k) Premarket Notifications (0)

FDA Recall History (0)

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