FDA Device Entity Profile: Align Technology, Inc.

Known Identifiers & Locations

FEI Numbers 3002519584, 3005695824, 3007527669, 3009646999, 3012138716, 3025237243

Owner Operator Numbers 9035576

Locations Covered Belen Heredia, CR; Cd. Juarez Chihuahua, MX; Petach Tikva Central, IL; San Jose, CA, US; Wroclaw Dolnoslaskie, PL

Registered Establishments (6)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
2953749	Align Technology, Inc.	San Jose, CA, US	Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198	View Details
3005695824	Align Technology de Costa Rica S.R.L	Belen Heredia, CR	Complaint File Establishment per 21 CFR 820.198	View Details
3007527669	Aligntech de Mexico S, de R. L. de C. V.	Cd. Juarez Chihuahua, MX	Manufacture Medical Device	View Details
3009646999	Align Technology, Ltd.	Petach Tikva Central, IL	Manufacture Medical Device	View Details
3012138716	Aligntech de Mexico S, de R. L. de C. V.	Cd. Juarez Chihuahua, MX	Manufacture Medical Device	View Details
3025237243	Align Technology AFAB Poland Sp. z o.o.	Wroclaw Dolnoslaskie, PL	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.