Ortek Therapeutics Inc

FDA Filings

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

Ortek Therapeutics Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3004498471
FEI Number3004498471
NameORTEK THERAPEUTICS, INC.
Owner & OperatorOrtek Therapeutics, Inc.
Contact Address4 Expressway Plaza
Roslyn Heights NY 11577 US
Official Correspondent
  • Mitch Goldberg
  • x-516-4844500-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4 Expressway Plaza
Roslyn Heights, NY 11577 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
ORTEK THERAPEUTICS, INC.
Ortek ECD2020-01-28
ORTEK THERAPEUTICS, INC.
Ortek ECD2020-01-28
Ortek Therapeutics, Inc.
Electronic Caries Detector2017-09-11
ORTEK THERAPEUTICS, INC.
PROCLUDE-SENSITIVE2001-02-01
ORTEK THERAPEUTICS, INC.
PROCLUDE2000-12-14

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