Home GUDID D00261D0101 iNterra™ iNoffice Nightguard Starter Kit
Primary DI D00261D0101
Brand iNterra™ iNoffice Nightguard Starter Kit
Company DENTSPLY INTERNATIONAL INC.
Model 61D010
Catalog number 61D010
Device description iNterra™ iNoffice Nightguard Starter Kit
Published 2016-09-21
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name EBI RESIN, DENTURE, RELINING, REPAIRING, REBASING MQC Mouthguard, prescription
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EBI Resin, Denture, Relining, Repairing, Rebasing Dental 2 MQC Mouthguard, Prescription Unknown U
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D00261D01062 Package HIBCC 6 Not in Commercial Distribution D00261D0101 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Custom-made mouthguard A custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Total Volume 50 Milliliter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep away from sunlight.
Regulatory Flags# DUNS number 083235549 Device count 1 DM exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D0026243451 Enhance® mini Finishing System 624345 624345 2022-04-11 D0026243551 Enhance® mini Finishing System 624355 624355 2022-04-11 D0026243651 Enhance® mini Finishing System 624365 624365 2022-04-11 D0026243751 Enhance® mini Finishing System 624375 624375 2022-10-13 D0026243851 Enhance® mini Finishing System 624385 624385 2022-04-11 D002624550001 Polytrays 62455000 62455000 2022-07-07 D002624550011 Polytrays 62455001 62455001 2022-07-07 D002624550021 Polytrays 62455002 62455002 2022-07-07 D002624551001 Polytrays 62455100 62455100 2022-07-07 D002624551011 Polytrays 62455101 62455101 2022-07-07 D002624551021 Polytrays 62455102 62455102 2022-07-07 D002624551031 Polytrays 62455103 62455103 2022-07-07 D002624551051 Polytrays 62455105 62455105 2022-07-07 D0026076071 Calibra® Bio Bioceramic Luting Cement 607607 607607 2022-04-20 D0026590301 Palodent® Sectional Matrix System 659030 659030 2019-04-02 D0026590701 Palodent® Sectional Matrix System 659070 659070 2019-04-02 D0026631001 AutoMate® 663100 663100 2019-04-02 D0013010121 Ceramco® 3 Powder Opaque i2/i4 301012 2016-09-21 D0013010211 Ceramco® 3 Powder Opaque D2 301021 2016-09-21 D0013010311 Ceramco® 3 Powder Opaque Modifier Yellow 301031 2016-09-21
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