| Primary Device ID | 00190730083630 |
| NIH Device Record Key | 2a1f9042-24e0-4c0e-ac21-9e371da0009d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | X7 |
| Version Model Number | 400-101 |
| Company DUNS | 781772017 |
| Company Name | ORTHO TECHNOLOGY, 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190730083630 [Primary] |
| DZN | INSTRUMENTS, DENTAL HAND |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-04 |
| Device Publish Date | 2022-04-26 |
| 00190730031068 | X7 Light Wire Bird Beak Plier (no groove) max wire .020 |
| 00190730031051 | X7 NiTi Three Jaw Plier max wire .020 |
| 00190730031044 | X7 Stop (V-Bend) Plier max wire .021 x .025 |
| 00190730031037 | X7 Hollow Chop Contouring Plier max wire .030 |
| 00190730031020 | X7 Lingual Arch Forming Plier |
| 00190730031013 | X7 Tweed Loop Forming Plier max wire .021x.025 |
| 00190730031006 | X7 Light Wire and with Groove Plier max wire .020 |
| 00190730030993 | X7 Jarabak Plier max wire .020 |
| 00190730030986 | X7 Crown Band Contouring Plier |
| 00190730030979 | X7 NiTi Distal Cinch Back Plier max wire .025 |
| 00190730030962 | X7 Adhesive Removing Plier Replacement Blade (non-carbide) (for item 400-124) pack of 1 |
| 00190730030955 | X7 Adhesive Removing Plier Replacement Teflon Tips 1/4" (5mm) pack of 6 (for 400-124) |
| 00190730030948 | X7 Adhesive Removing Plier |
| 00190730030931 | X7 Debonding Plier |
| 00190730030924 | X7 Angulated Debonding Plier |
| 00190730030917 | X7 Posterior Band Remover Replacement Tips 1/4" pack of 6 (for item 400-120) |
| 00190730030900 | X7 Posterior Band Remover Replacement Tips 3/16" Pack of 6 (for Item 400-120) |
| 00190730030894 | X7 Posterior Band Removing Plier, Long |
| 00190730030887 | X7 Three Jaw Plier max wire .030 |
| 00190730030870 | X7 Rectangular Arch Forming Plier max .021x.025 |
| 00190730030863 | X7 Standard How Utility Plier |
| 00190730030856 | X7 Small Weingart Plier |
| 00190730030849 | X7 Bird Beak Plier with Cutter max wire .021x.025 |
| 00190730030832 | X7 Bird Beak Plier max wire .030 |
| 00190730030825 | X7 Long Tapered Bird Beak Plier max wire .021x.025 |
| 00190730030818 | X7 Micro Mini Pin & Lig Cutter 15 Degree Angled max wire .012 |
| 00190730030801 | X7 Hard Wire Cutter max wire .021x.025 |
| 00190730030795 | X7 Multi-Use Cutter max wire .015 |
| 00190730030788 | X7 Mini Pin & Lig Cutter max wire .012 |
| 00190730030771 | X7 Micro Mini Pin & Ligature Cutter max wire .012 |
| 00190730030764 | X7 Distal End Cutter Replacement Silicone Inserts 3 per pack (for 400-103 ) |
| 00190730030757 | X7 Distal End Cutter and Flush Cut max wire size .019 x .025 |
| 00190730030740 | X7 Distal End Cutter Max wire size .021x.025 |
| 00190730083951 | Light Wire Bird Beak Plier |
| 00190730083944 | NiTi Three Jaw Plier |
| 00190730083937 | Stop (V-Bend) Plier |
| 00190730083920 | Hollow Chop Contouring Plier |
| 00190730083913 | Lingual Arch Forming Plier |
| 00190730083906 | Tweed Loop Forming Plier |
| 00190730083890 | Light Wire Bird Beak with Groove Plier |
| 00190730083883 | Jarabak Plier |
| 00190730083876 | Crown Band Contouring Plier |
| 00190730083869 | NiTi Distal Cinch Back Plier |
| 00190730083852 | Replacement Blades |
| 00190730083845 | Replacement Teflon Tips |
| 00190730083838 | Adhesive Removing Plier |
| 00190730083821 | Debonding Plier |
| 00190730083814 | Angulated Debonding Plier |
| 00190730083807 | Replacement Teflon Tips - 1/4" |
| 00190730083791 | Replacement Teflon Tips - 3/16" |