Gc Orthodontics

FDA Filings

This page includes the latest FDA filings for Gc Orthodontics. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010259872
• FEI Number: 3010259872
• Name: GC Orthodontics Europe GmbH
• Owner & Operator: GC Orthodontics
• Contact Address: GC Orthodontics Inc. 3737 W. 127th Street; Alsip IL 60803 US
• Official Correspondent:
  • Mark Heiss
  • x-708-9263090-x
• US Agent:
  • Mark Heiss
  • GC ORTHODONTICS EUROPE GmbH
  • 708 9263090
  • 708 9269100
  • mark_heiss@gcamerica.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Harkortstrasse 2 ; Breckerfeld Nordrhein-Westfalen, 58339 DE
• Establishment Type:
  • Repack or Relabel Medical Device
  • Reprocess Single-Use Device

• Registration Number: 3010032042
• FEI Number: 3010032042
• Name: GC Orthodontics America Inc.
• Owner & Operator: GC Orthodontics
• Contact Address: GC Orthodontics Inc. 3737 W. 127th Street; Alsip IL 60803 US
• Official Correspondent:
  • Mark Heiss
  • x-708-9263090-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 3737 W. 127th Street ; Alsip, IL 60803 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
EJB GC Orthodontics America Inc. [GC Orthodontics]	DS Interproximal Reduction	2019-05-29
EGD GC Orthodontics Europe GmbH [GC Orthodontics]	Orthosil	2016-07-15
EGD GC Orthodontics Europe GmbH [GC Orthodontics]	Exerbites	2016-07-15
EGD GC Orthodontics Europe GmbH [GC Orthodontics]	Chewing Aligner	2016-07-15
EGD GC Orthodontics America Inc. [GC Orthodontics]	Orthosil	2016-07-15
EGD GC Orthodontics America Inc. [GC Orthodontics]	Exerbites	2016-07-15
EGD GC Orthodontics America Inc. [GC Orthodontics]	Chewing Aligner	2016-07-15
EAX GC Orthodontics Europe GmbH [GC Orthodontics]	Mirrors	2016-07-15
EAX GC Orthodontics America Inc. [GC Orthodontics]	Mirrors	2016-07-15
PMN K150128 | DYH GC Orthodontics America Inc. [GC Orthodontics]	GC Ortho Connect & GC Ortho Etching Gel	2015-07-21
PMN K143667 | DYH GC Orthodontics America Inc. [GC Orthodontics]	GC KommonBase	2015-06-23
KMY GC Orthodontics Europe GmbH [GC Orthodontics]	GC Ortho	2013-08-19
KMY GC Orthodontics America Inc. [GC Orthodontics]	GC Ortho	2013-08-19
EJL GC Orthodontics Europe GmbH [GC Orthodontics]	GC Ortho	2013-08-19
EJL GC Orthodontics America Inc. [GC Orthodontics]	GC Ortho	2013-08-19
EIL GC Orthodontics Europe GmbH [GC Orthodontics]	GC Ortho	2013-08-19
EIL GC Orthodontics America Inc. [GC Orthodontics]	GC Ortho	2013-08-19
ECT GC Orthodontics Europe GmbH [GC Orthodontics]	GC Ortho	2013-08-19
ECT GC Orthodontics America Inc. [GC Orthodontics]	GC Ortho	2013-08-19
ECS GC Orthodontics Europe GmbH [GC Orthodontics]	GC Ortho	2013-08-19
ECS GC Orthodontics America Inc. [GC Orthodontics]	GC Ortho	2013-08-19
ECR GC Orthodontics Europe GmbH [GC Orthodontics]	GC Ortho	2013-08-19
ECR GC Orthodontics America Inc. [GC Orthodontics]	GC Ortho	2013-08-19
DYT GC Orthodontics Europe GmbH [GC Orthodontics]	GC Ortho	2013-08-19
DYT GC Orthodontics America Inc. [GC Orthodontics]	GC Ortho	2013-08-19
ECQ GC Orthodontics Europe GmbH [GC Orthodontics]	GC Ortho	2013-01-24
ECQ GC Orthodontics America Inc. [GC Orthodontics]	GC Ortho	2013-01-24
ECP GC Orthodontics Europe GmbH [GC Orthodontics]	GC Ortho	2013-01-24
ECP GC Orthodontics America Inc. [GC Orthodontics]	GC Ortho	2013-01-24
ECM GC Orthodontics Europe GmbH [GC Orthodontics]	GC Ortho	2013-01-24
ECM GC Orthodontics America Inc. [GC Orthodontics]	GC Ortho	2013-01-24
DZD GC Orthodontics Europe GmbH [GC Orthodontics]	GC Orthodontics	2013-01-24
DZD GC Orthodontics America Inc. [GC Orthodontics]	GC Orthodontics	2013-01-24
DYO GC Orthodontics Europe GmbH [GC Orthodontics]	GC Orthodontics	2013-01-24
DYO GC Orthodontics America Inc. [GC Orthodontics]	GC Orthodontics	2013-01-24

Similar & Related FDA Registered Companies

• GC ORTHODONTICS EUROPE GmbH
• GC Orthodontics America Inc.