FDA.report

Dream TAP

Primary DI
D745TAPD0
Brand
Dream TAP
Company
James R. Glidewell, Dental Ceramics, Inc.
Model
TAPD
Catalog number
TAPD
Device description
Device for treatment of mild to moderate obstructive sleep apnea
Published
2019-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LRKDevice, anti-snoring

Product Code Classifications

CodeDeviceSpecialtyClass
LRKDevice, Anti-SnoringDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D745TAPD0PrimaryHIBCC0

GMDN Terms

TermDefinition
Mandible-repositioning sleep-disordered breathing orthosisA removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00store at room temperature
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)854-7256XX@XX.XX

Regulatory Flags

DUNS number
021228671
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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D745701123BRX00350BruxZir™ TintEFX Coloring Liquid70-1123-BRX003570-1123-BRX00352023-06-23
D745701123BRX00360BruxZir™ TintEFX Coloring Liquid70-1123-BRX003670-1123-BRX00362023-06-23
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D745701123BRX00380BruxZir™ TintEFX Coloring Liquid70-1123-BRX003870-1123-BRX00382023-06-23
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D745701185BXP05720BruxZir70-1185-BXP057270-1185-BXP05722023-06-12

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