Custom Smiles Sleep Department

FDA Filings

This page includes the latest FDA filings for Custom Smiles Sleep Department. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3014945982
FEI Number3014945982
NameCUSTOM SMILES SLEEP DEPARTMENT
Owner & OperatorCustom Smiles, Inc.
Contact Address2530 Lane Street
Kannapolis NC 28083 US
Official Correspondent
  • Michael Creech
  • x-919-8800917-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2530 Lane Street
Kannapolis, NC 28083 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
CUSTOM SMILES SLEEP DEPARTMENT [Custom Smiles, Inc.]
Emerson Myerson Appliance2018-11-15
CUSTOM SMILES SLEEP DEPARTMENT [Custom Smiles, Inc.]
Dorsal Appliance2018-11-15
CUSTOM SMILES SLEEP DEPARTMENT [Custom Smiles, Inc.]
Acrylic Herbst Splint Appliance2018-11-15
CUSTOM SMILES SLEEP DEPARTMENT [Custom Smiles, Inc.]
Oasys/Oral Airway System2018-11-15
CUSTOM SMILES SLEEP DEPARTMENT [Custom Smiles, Inc.]
Oasys/Oral Airway System2018-11-15

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