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 |
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 |
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 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 |
MQC | Mouthguard, prescription |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2024-01-30 |
Device Publish Date | 2016-09-21 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INTERRA 90560842 not registered Live/Pending |
InTerra 2021-03-04 |
INTERRA 86947171 not registered Dead/Abandoned |
ADAMA MAKHTESHIM LTD. 2016-03-21 |
INTERRA 86846339 5286975 Live/Registered |
DUPONT ELECTRONICS, INC. 2015-12-11 |
INTERRA 85948953 4577203 Live/Registered |
Logix Insulated Concrete Forms Ltd. 2013-06-03 |
INTERRA 85755980 not registered Dead/Abandoned |
ADAMA MAKHTESHIM LTD. 2012-10-17 |
INTERRA 85305950 not registered Dead/Abandoned |
Paul Friant 2011-04-27 |
INTERRA 85000205 not registered Dead/Abandoned |
Fair Planet Consulting, LLC 2010-03-28 |
INTERRA 78289011 2877560 Live/Registered |
DUPONT ELECTRONICS, INC. 2003-08-19 |
INTERRA 77686087 not registered Dead/Abandoned |
Waltner,Pamela J. 2009-03-08 |
INTERRA 77640004 3650936 Live/Registered |
Interra Credit Union 2008-12-24 |
INTERRA 77448224 3632762 Live/Registered |
DENTSPLY SIRONA INC. 2008-04-15 |
INTERRA 77351241 not registered Dead/Abandoned |
Interra International, Inc. 2007-12-13 |