Primary Device ID | 00817645020016 |
NIH Device Record Key | cb364af5-3d41-49c8-a3e0-9112fa68b43b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OrthoMax® |
Version Model Number | 905R |
Catalog Number | 905R |
Company DUNS | 081365847 |
Company Name | Six Month Smiles |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | 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 Issuing Agency | Device ID |
---|---|
GS1 | 00817645020016 [Primary] |
DYH | Adhesive, Bracket And Tooth Conditioner, Resin |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-11-16 |
Device Publish Date | 2016-09-24 |
00817645020160 | OrthoMax® - Direct Bond 5g (Non Flouride) |
00817645020016 | OrthoMax® - Direct Bond 5g (Direct Bonding) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ORTHOMAX 98335501 not registered Live/Pending |
Medline Industries, LP 2023-12-29 |
![]() ORTHOMAX 88045342 not registered Live/Pending |
Gladkov, Alex 2018-07-19 |
![]() ORTHOMAX 85509886 4194170 Live/Registered |
SMS OPCO, LLC 2012-01-05 |
![]() ORTHOMAX 85300629 4214869 Dead/Cancelled |
Noveq LLC 2011-04-21 |
![]() ORTHOMAX 74593887 1929870 Dead/Cancelled |
Autometric, Inc. 1994-11-02 |
![]() ORTHOMAX 74593151 not registered Dead/Abandoned |
Autometric, Incorporated 1994-10-31 |