iNterra™ iNoffice Nightguard 61D040

GUDID D00261D04062

iNterra™ iNoffice Nightguard Refill Package, Large Arch, 6

DENTSPLY INTERNATIONAL INC.

Custom-made mouthguard

• Primary Device ID: D00261D04062
• NIH Device Record Key: d2ad0f94-d912-470d-ba40-80bd33c252cf
• Commercial Distribution Discontinuation: 2023-09-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: iNterra™ iNoffice Nightguard
• Version Model Number: 61D040
• Catalog Number: 61D040
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL INC.
• Device Count: 6
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D00261D0400 [Unit of Use]
HIBCC	D00261D0401 [Primary]
HIBCC	D00261D04062 [Package]; Contains: D00261D0401; Package: Box [6 Units]; Discontinued: 2023-09-05; Not in Commercial Distribution

FDA Product Code

• MQC: Mouthguard, prescription

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-01-30
• Device Publish Date: 2016-09-21

On-Brand Devices [iNterra™ iNoffice Nightguard]

• D00261D1000: iNterra™ VLC Curing Unit 120V
• D00261D03062: iNterra™ iNoffice Nightguard Refill Package, Medium Arch, 6
• D00261D04062: iNterra™ iNoffice Nightguard Refill Package, Large Arch, 6
• D00261D02062: iNterra™ iNoffice Nightguard Refill Package, Small Arch, 6