| Primary Device ID | D909700004T1 |
| NIH Device Record Key | 48775532-dfdb-429f-9a18-cdcce30e3593 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BUTTON BONDER TIP |
| Version Model Number | 700-004T |
| Catalog Number | 700-004T |
| 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 | D909700004T1 [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 |
| D9098001290 - SPECTRUM | 2023-07-06 SPECTRUM LINGUAL ARCH FORMING PLIER |
| D9098001302 - SPECTRUM | 2023-07-06 SPECTRUM TORQUING PLIER SET W/ WIDE KEY |
| D9098001311 - SPECTRUM | 2023-07-06 SPECTRUM WIDE REPLACEMENT KEY |
| D9098001321 - SPECTRUM | 2023-07-06 SPECTRUM THREE PRONG FACEMASK/ FACEBOW PLIER |
| D90980014111 - MOLAR OPENING TOOL | 2023-07-06 SLB MOLAR OPENING TOOL |
| D90980014616 - OPENING TOOL | 2023-07-06 ECLIPSE SLB OPENING TOOL |
| D90980014717 - CLOSING TOOL | 2023-07-06 ECLIPSE SLB CLOSING TOOL |
| D90980014818 - ECLIPSE SLB CLOSING TOOL | 2023-07-06 ECLIPSE SLB CLOSING TOOL W/ WIRE DIRECTOR |