Gergens Orthodontic Lab

FDA Filings

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

FDA Registration(s)

• Registration Number: 3008274496
• FEI Number: 3008274496
• Name: GERGENS ORTHODONTIC LAB
• Owner & Operator: Gergens Orthodontic Lab
• Contact Address: 1745 West Deer Valley Rd Suite 112; Phoenix AZ 85027 US
• Official Correspondent:
  • David S Gergen
  • x-623-8796066-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1745 West Deer Valley Rd Suite 112; Phoenix, AZ 85027 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3009888648
• FEI Number: 3009888648
• Name: Gergens Orthodontic Lab
• Owner & Operator: Gergens Orthodontic Lab
• Contact Address: 1745 West Deer Valley Rd Suite 112; Phoenix AZ 85027 US
• Official Correspondent:
  • David S Gergen
  • x-623-8796066-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 11825 State Route 40 Ste 101 ; Dunlap, IL 61525 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
DZC GERGENS ORTHODONTIC LAB	Vivos DNA Appliance	2019-07-10
PMN K130067 | LRK GERGENS ORTHODONTIC LAB	mRNA Appliance	2018-12-21
PMN K143591 GERGENS ORTHODONTIC LAB	Dorsal Appliance	2015-04-15
PMN K113126 | LRK GERGENS ORTHODONTIC LAB	Acylic Herbst	2013-08-15
PMN K113126 GERGENS ORTHODONTIC LAB	ACRYLIC HERBST APPLIANCE	2013-07-17
PMN K111009 | LRK Gergens Orthodontic Lab	Acrylic Herbst	2012-11-16
PMN K062951 | LRK GERGENS ORTHODONTIC LAB	TAP	2010-01-20