| Primary Device ID | D9097000041 |
| NIH Device Record Key | e2466552-90a5-4e0c-83da-d67c2abba5ea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BUTTON BONDER |
| Version Model Number | 700-004 |
| Catalog Number | 700-004 |
| Company DUNS | 020956330 |
| Company Name | Ortho Arch Company 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D9097000041 [Primary] |
| EGD | Wax, Dental, Intraoral |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-05 |
| Device Publish Date | 2023-06-27 |
| D90927010916 - ORTHO ARCH | 2025-10-07 ORTHO-LINKS LINGUAL RETAINER WIRE 8" (8/PK) |
| D90927021918 - ORTHO ARCH | 2025-10-07 BONDABLE MULTI HOOK (10) |
| D90943001914 - ORTHO ARCH | 2025-10-07 CRIMPABLE CURVED MULTI HOOK - RIGHT (10 PACK) |
| D9094300201 - ORTHO ARCH | 2025-10-07 CRIMPABLE CURVED MULTI HOOK - LEFT (10 PACK) |
| D90992402115 - ORTHO ARCH | 2025-10-07 .018 L6R SINGLE CONVERTIBLE BT W/HOOK -25T 8DO BONDABLE (5) |
| D90992402216 - ORTHO ARCH | 2025-10-07 .018 L6L SINGLE CONVERTIBLE -25T DIRECT BOND (5) |
| D909924023G1 - ORTHO ARCH | 2025-10-07 .018/.045 U6R DOUBLE CONVERTIBLE -10 TORQUE DIRECT BOND (5) |
| D909924024G1 - ORTHO ARCH | 2025-10-07 .018/.045 U6L DOUBLE CONVERTIBLE -10 TORQUE DIRECT BOND (5) |