| Primary Device ID | 08800053064729 |
| NIH Device Record Key | ae3b3767-15dd-4fbd-bfa4-a6c46afbfda3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | I-FIX Angled Type ScanBody |
| Version Model Number | DFASBS |
| Company DUNS | 694721181 |
| Company Name | DENTIS CO. ,LTD |
| 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 | 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 | 08800053064729 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800053064729]
Moist Heat or Steam Sterilization
[08800053064729]
Moist Heat or Steam Sterilization
[08800053064729]
Moist Heat or Steam Sterilization
[08800053064729]
Moist Heat or Steam Sterilization
[08800053064729]
Moist Heat or Steam Sterilization
[08800053064729]
Moist Heat or Steam Sterilization
[08800053064729]
Moist Heat or Steam Sterilization
[08800053064729]
Moist Heat or Steam Sterilization
[08800053064729]
Moist Heat or Steam Sterilization
[08800053064729]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-26 |
| Device Publish Date | 2024-11-18 |
| 08800053064767 | I-FIX Angled Type ScanBody (DFASBLS) |
| 08800053064750 | I-FIX Angled Type ScanBody (DFASBSS) |
| 08800053064736 | I-FIX Angled Type ScanBody (DFASBL) |
| 08800053064729 | I-FIX Angled Type ScanBody (DFASBS) |