| Primary Device ID | 00850048985261 |
| NIH Device Record Key | 21bf802c-6f65-491b-9c0d-9136d08b4ef6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FASTBRACES® Classic Clear UL1 |
| Version Model Number | Classic Clear UL1 |
| Catalog Number | 99-U1-2L |
| Company DUNS | 047033213 |
| Company Name | Orthoworld, L.L.C. |
| 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 | 9728679473 |
| info@fastbraces.com | |
| Phone | 9728679473 |
| info@fastbraces.com | |
| Phone | 9728679473 |
| info@fastbraces.com | |
| Phone | 9728679473 |
| info@fastbraces.com | |
| Phone | 9728679473 |
| info@fastbraces.com | |
| Phone | 9728679473 |
| info@fastbraces.com | |
| Phone | 9728679473 |
| info@fastbraces.com | |
| Phone | 9728679473 |
| info@fastbraces.com | |
| Phone | 9728679473 |
| info@fastbraces.com | |
| Phone | 9728679473 |
| info@fastbraces.com | |
| Phone | 9728679473 |
| info@fastbraces.com | |
| Phone | 9728679473 |
| info@fastbraces.com | |
| Phone | 9728679473 |
| info@fastbraces.com | |
| Phone | 9728679473 |
| info@fastbraces.com | |
| Phone | 9728679473 |
| info@fastbraces.com | |
| Phone | 9728679473 |
| info@fastbraces.com | |
| Phone | 9728679473 |
| info@fastbraces.com | |
| Phone | 9728679473 |
| info@fastbraces.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850048985261 [Primary] |
| NJM | Bracket, Ceramic, Orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-22 |
| Device Publish Date | 2024-05-14 |
| 00850048985025 - Fastbraces® CLASSIC Metal Bracket Kit | 2024-05-22 Orthodontic Bracket Kit |
| 00850048985032 - Fastbraces® CLASSIC COMBO™ Bracket Kit | 2024-05-22 Orthodontic Bracket Kit |
| 00850048985049 - Fastbraces® CLASSIC Clear Bracket Kit | 2024-05-22 Orthodontic Bracket Kit |
| 00850048985056 - Fastbraces® TURBO™ Bracket Kit | 2024-05-22 Orthodontic Bracket Kit |
| 00850048985063 - Fastbraces® COMBO TURBO™ Bracket Kit | 2024-05-22 Orthodontic Bracket Kit |
| 00850048985070 - Fastbraces® Turbo™ Xtra Bracket Kit | 2024-05-22 Orthodontic Bracket Kit |
| 00850048985087 - Fastbraces® Turbo® Xtra Archwires | 2024-05-22 Orthodontic Archwire |
| 00850048985094 - Fastbraces® Turbo® Archwires | 2024-05-22 Orthodontic Archwire |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FASTBRACES 76622973 3044111 Live/Registered |
Oralect Licensing, Ltd. 2004-12-02 |
![]() FASTBRACES 75248721 2130607 Live/Registered |
ORALECT LICENSING, LTD. 1997-02-27 |