| Primary Device ID | 00842452100408 |
| NIH Device Record Key | aa07b361-8521-4dea-9560-33a2fa3b38e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | .022 Comp Clear Six™ Brackets-5 Case Kit |
| Version Model Number | 710-500 |
| Catalog Number | 710-500 |
| 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 | true |
| 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 | 00842452100408 [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 |
| 00842452100491 - Adhere™ Light Cure Adhesive 5g Syringe | 2018-07-06 Light Cure Adhesive Paste In Syringe For Direct Bonding Orthodontic Brackets |
| 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 |