TAP 3 TAP3

GUDID D745TAP30

Device for treatment of mild to moderate obstructive sleep apnea

James R. Glidewell, Dental Ceramics, Inc.

Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: D745TAP30
• NIH Device Record Key: c33dfc30-9115-46e3-af5f-87d2a5018500
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TAP 3
• Version Model Number: TAP3
• Catalog Number: TAP3
• Company DUNS: 021228671
• Company Name: James R. Glidewell, Dental Ceramics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX
• Phone: +1(800)854-7256
• Email: XX@XX.XX

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D745TAP30 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062951

FDA Product Code

• LRK: Device, anti-snoring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-01
• Device Publish Date: 2019-09-23

Devices Manufactured by James R. Glidewell, Dental Ceramics, Inc.

• D7457025AM0 - BruxZir: 2023-08-21 25 Automix Applicator Tips
• D74570BZDC0 - BruxZir: 2023-08-18 BruxZir™ Dual Cure Resin Cement
• D745701026CAP00091 - Metal Quadrant Impression Trays: 2023-07-13 Metal Quadrant Impression Trays, 50-pack
• D745701026CAP00101 - Metal Quadrant Impression Trays: 2023-07-13 Metal Quadrant Impression Trays, 250-pack
• D745701123BRX00250 - BruxZir™ TintEFX Coloring Liquid: 2023-07-03 BruxZir™ TintEFX Coloring Liquid - G00
• D745701123BRX00260 - BruxZir™ TintEFX Coloring Liquid: 2023-07-03 BruxZir™ TintEFX Coloring Liquid - G0
• D745701123BRX00270 - BruxZir™ TintEFX Coloring Liquid: 2023-07-03 BruxZir™ TintEFX Coloring Liquid - G1
• D745701123BRX00280 - BruxZir™ TintEFX Coloring Liquid: 2023-07-03 BruxZir™ TintEFX Coloring Liquid - G3