Primary Device ID | D82850001900 |
NIH Device Record Key | 54f62806-b2d2-47b3-a9df-b1f416d7479a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Twin Block |
Version Model Number | 5000190 |
Company DUNS | 113352686 |
Company Name | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC |
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 | true |
Lot Batch | false |
Serial Number | false |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D82850001900 [Primary] |
DYJ | Retainer, Screw Expansion, Orthodontic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2024-10-21 |
Device Publish Date | 2022-12-30 |
D82850001900 - Twin Block | 2024-10-21 |
D82850001900 - Twin Block | 2024-10-21 |
D82853004020 - Rickonator | 2024-10-21 |
D82851001560 - Bioliner Plus | 2023-02-20 |
D82852000920 - Vivos mmRNA | 2021-11-29 |
D8281330003 - FUJI SC BAND PASTE PAK | 2018-07-06 |
D8281330121 - FUJI LC BAND AUTOMIX | 2018-07-06 |
D8281330171 - ULTRA BAND LOK CLEAR | 2018-07-06 |
D8281330205 - LIGHT BOND PASTE TIPS | 2018-07-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TWIN BLOCK 74456347 not registered Dead/Abandoned |
RMO, Inc. 1993-11-03 |