Comfort Splint COMSPL

GUDID D745COMSPL0

Device to alleviate pain caused by bruxing or clenching of teeth

James R. Glidewell, Dental Ceramics, Inc.

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• Primary Device ID: D745COMSPL0
• NIH Device Record Key: 18ee733a-abae-465e-92f2-db795ac12a7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comfort Splint
• Version Model Number: COMSPL
• Catalog Number: COMSPL
• 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

Operating and Storage Conditions

• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D745COMSPL0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121365

FDA Product Code

• MQC: Mouthguard, prescription

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

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