| Primary Device ID | D115TB3214001 |
| NIH Device Record Key | 9f43e764-0e69-43fb-a3b8-242476472dd8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORJ |
| Version Model Number | TB32-1400 |
| Company DUNS | 949163229 |
| Company Name | Fortune Worldwide LLC |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D115TB3214001 [Primary] |
| EJF | Bracket, Metal, 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 | 2022-11-07 |
| Device Publish Date | 2022-10-28 |
| D115W62112181 | Orthodontic Niti Coil Springs |
| D115W62110181 | Orthodontic Niti Coil Springs |
| D115W61212121 | Orthodontic Niti Coil Springs |
| D115W61212091 | Orthodontic Niti Coil Springs |
| D115W61212061 | Orthodontic Niti Coil Springs |
| D115W61210121 | Orthodontic Niti Coil Springs |
| D115W61210091 | Orthodontic Niti Coil Springs |
| D115W61210061 | Orthodontic Niti Coil Springs |
| D115W12112U1 | Orthodontic Niti Archwires for Teeth Correction |
| D115TB3224001 | Orthodontic Metal Brackets for Teeth Correction |
| D115TB3214001 | Orthodontic Metal Brackets for Teeth Correction |
| D115TB3124001 | Orthodontic Metal Brackets for Teeth Correction |
| D115TB3114001 | Orthodontic Metal Brackets for Teeth Correction |
| D115TB2224001 | Orthodontic Metal Brackets for Teeth Correction |
| D115TB2214001 | Orthodontic Metal Brackets for Teeth Correction |
| D115TB2124001 | Orthodontic Metal Brackets for Teeth Correction |
| D115TB2114001 | Orthodontic Metal Brackets for Teeth Correction |
| D115TB1214001 | Orthodontic Metal Brackets for Teeth Correction |
| D115TB1114001 | Orthodontic Metal Brackets for Teeth Correction |
| D115J62251151 | Orthodontic Metal Tubes for Teeth Correction |
| D115D6011101 | Orthodontic Metal Bands for Teeth Correction |
| D115W12120U1 | Orthodontic Niti Archwires for Teeth Correction |
| D115W1211925U1 | Orthodontic Niti Archwires for Teeth Correction |
| D115W1211925L1 | Orthodontic Niti Archwires for Teeth Correction |
| D115W12118U1 | Orthodontic Niti Archwires for Teeth Correction |
| D115W12118L1 | Orthodontic Niti Archwires for Teeth Correction |
| D115W1211825U1 | Orthodontic Niti Archwires for Teeth Correction |
| D115W1211825L1 | Orthodontic Niti Archwires for Teeth Correction |
| D115W1211725U1 | Orthodontic Niti Archwires for Teeth Correction |
| D115W1211725L1 | Orthodontic Niti Archwires for Teeth Correction |
| D115W12116U1 | Orthodontic Niti Archwires for Teeth Correction |
| D115W12116L1 | Orthodontic Niti Archwires for Teeth Correction |
| D115W1211622U1 | Orthodontic Niti Archwires for Teeth Correction |
| D115W1211622L1 | Orthodontic Niti Archwires for Teeth Correction |
| D115W12114U1 | Orthodontic Niti Archwires for Teeth Correction |
| D115W12114L1 | Orthodontic Niti Archwires for Teeth Correction |
| D115W12112L1 | Orthodontic Niti Archwires for Teeth Correction |
| D115J72251451 | Orthodontic Metal Tubes for Teeth Correction |
| D115J72251351 | Orthodontic Metal Tubes for Teeth Correction |
| D115J72251251 | Orthodontic Metal Tubes for Teeth Correction |
| D115J72251151 | Orthodontic Metal Tubes for Teeth Correction |
| D115J72151451 | Orthodontic Metal Tubes for Teeth Correction |
| D115J72151351 | Orthodontic Metal Tubes for Teeth Correction |
| D115J72151251 | Orthodontic Metal Tubes for Teeth Correction |
| D115J72151151 | Orthodontic Metal Tubes for Teeth Correction |
| D115J63251451 | Orthodontic Metal Tubes for Teeth Correction |
| D115J63251351 | Orthodontic Metal Tubes for Teeth Correction |
| D115J63251251 | Orthodontic Metal Tubes for Teeth Correction |
| D115J63251151 | Orthodontic Metal Tubes for Teeth Correction |
| D115J62251451 | Orthodontic Metal Tubes for Teeth Correction |