FDA Device Entity Profile: Coltene/Whaledent AG

Known Identifiers & Locations

FEI Numbers 1000273801, 2416455, 3002806620, 3012832388, 5615

Owner Operator Numbers 9089944

Locations Covered ALTSTAETTEN Sankt Gallen, CH; BESANCON Doubs, FR; CUYAHOGA FALLS, OH, US; Mount Pleasant, SC, US; TORONTO Ontario, CA

Registered Establishments (5)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
2416455	COLTENE/WHALEDENT INC.	CUYAHOGA FALLS, OH, US	Manufacture Medical Device	View Details
3012832388	DIATECH DENTAL INC	Mount Pleasant, SC, US	Manufacture Medical Device	View Details
8030962	Micro-Mega SA	BESANCON Doubs, FR	Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)	View Details
8043629	SCICAN LTD.	TORONTO Ontario, CA	Manufacture Medical Device	View Details
9613375	COLTENE/WHALEDENT AG	ALTSTAETTEN Sankt Gallen, CH	Manufacture Medical Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.