Primary Device ID | 00842452100262 |
NIH Device Record Key | 0adfdb59-b1b6-4638-a883-3d9f6632b480 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Comp Plus "T"™ LL 1st Bicuspid Roth .022 |
Version Model Number | 710-923T |
Catalog Number | 710-923T |
Company DUNS | 011050583 |
Company Name | ORTHO SPECIALTIES |
Device Count | 1 |
DM Exempt | false |
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 | 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 |
Phone | 800-637-1237 |
contactus@orthospecialties.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00842452100262 [Primary] |
DYW | Bracket, Plastic, 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 | 2018-03-29 |
Device Publish Date | 2016-09-24 |
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00842452100507 - Adhere™ Light Cure Adhesive Kit | 2018-07-06 Light Cure Adhesive Kit For Direct Bonding Orthodontic Brackets |
00842452100514 - Adhere™ Light Cure Adhesive Tips | 2018-07-06 Light Cure Adhesive Preloaded Tips For Direct Bonding Orthodontic Brackets |
00842452100521 - Adhere™ Light Cure Adhesive Primer | 2018-07-06 Light Cure Adhesive Primer For Direct Bonding Orthodontic Brackets |
00842452100538 - Adhere™ Enamel Etch Conditioner | 2018-07-06 Phosphoric Acid Etch For Direct Bonding Orthodontic Brackets |
00842452100545 - Adhere™ Self Cure Adhesive Kit | 2018-07-06 Self Curing Adhesive Kit For Direct Bonding Orthodontic Brackets |
00842452100552 - Adhere™ Self Cure Adhesive Tips | 2018-07-06 Self Curing Adhesive Preloaded Tips For Direct Bonding Orthodontic Brackets |
00842452100569 - Adhere™ Self Cure Activator | 2018-07-06 Self Curing Adhesive Primer For Direct Bonding Orthodontic Brackets |