Silent Nite Sleep Appliance with Glidewell Hinge SNGLHG

GUDID D745SNGLHG0

Silent Nite Sleep Appliance with Glidewell Hinge

James R. Glidewell, Dental Ceramics, Inc.

Mandible-repositioning sleep-disordered breathing orthosis
Primary Device IDD745SNGLHG0
NIH Device Record Key773531a4-6690-4c81-835e-57b71409a6f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilent Nite Sleep Appliance with Glidewell Hinge
Version Model NumberSNGLHG
Catalog NumberSNGLHG
Company DUNS021228671
Company NameJames R. Glidewell, Dental Ceramics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx
Phone+1(800)854-7256
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD745SNGLHG0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LRKDevice, anti-snoring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-08
Device Publish Date2022-06-30

On-Brand Devices [Silent Nite Sleep Appliance with Glidewell Hinge]

D745SNGLHGXPHU0Silent Nite Sleep Appliance with Glidewell Hinge Original Part Upper
D745SNGLHGXPHL0Silent Nite Sleep Appliance with Glidewell Hinge Original Part Lower
D745SNGLHGXP0Silent Nite Sleep Appliance with Glidewell Hinge Original Parts
D745SNGLHGHU0Silent Nite Sleep Appliance with Glidewell Hinge Half Upper
D745SNGLHGHL0Silent Nite Sleep Appliance with Glidewell Hinge Half Lower
D745SNGLHGADJ0Silent Nite Sleep Appliance with Glidewell Hinge Adjust
D745SNGLHG0Silent Nite Sleep Appliance with Glidewell Hinge

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