| Primary Device ID | 08806169126092 |
| NIH Device Record Key | abf7250d-2631-460b-88b8-0cb781ee978b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OneQ-SL Implant |
| Version Model Number | DISOF4847103 |
| Catalog Number | DISOF4847103s |
| Company DUNS | 694721181 |
| Company Name | DENTIS CO. ,LTD |
| 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 | true |
| 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 | 08806169126092 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-07-27 |
| Device Publish Date | 2016-02-03 |
| 08800053053662 - Aqua Tip | 2024-12-25 Aqua Tip (DSSAT31) |
| 08800053053679 - Aqua Tip | 2024-12-25 Aqua Tip (DSSAT41) |
| 08800053064729 - I-FIX Angled Type ScanBody | 2024-11-26 I-FIX Angled Type ScanBody (DFASBS) |
| 08800053064736 - I-FIX Angled Type ScanBody | 2024-11-26 I-FIX Angled Type ScanBody (DFASBL) |
| 08800053064743 - I-FIX Angled Type ScanBody Screw | 2024-11-26 I-FIX Angled Type ScanBody Screw (DFSBS) |
| 08800053064750 - I-FIX Angled Type ScanBody | 2024-11-26 I-FIX Angled Type ScanBody (DFASBSS) |
| 08800053064767 - I-FIX Angled Type ScanBody | 2024-11-26 I-FIX Angled Type ScanBody (DFASBLS) |
| 08800053093743 - S250 Series(Ceiling, Mobile) | 2024-11-07 AC 100-240V, 50/60HZ, 61-94VA |