| Primary Device ID | 06947600321811 |
| NIH Device Record Key | 029e7247-f9a6-40eb-807e-9355ed9b2e5d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bone Level Tapered Implant,Φ4.1mm,L18mm,No-mount |
| Version Model Number | 318010G |
| Company DUNS | 527603266 |
| Company Name | BIO CONCEPT 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 | 06947600321811 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-15 |
| Device Publish Date | 2025-12-05 |
| 06947600321811 - Bone Level Tapered Implant,Φ4.1mm,L18mm,No-mount | 2025-12-15 |
| 06947600321811 - Bone Level Tapered Implant,Φ4.1mm,L18mm,No-mount | 2025-12-15 |
| 06947600330035 - Bone Level Tapered Implant,Φ4.8mm,L18mm,No-mount | 2025-12-15 |
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| 06936616987777 - Osteotome maxillary sinus elevation Drill,Φ2.8mm, L37mm | 2025-04-02 |
| 06936616987784 - Osteotome maxillary sinus elevation Drill,Φ3.1mm, L31mm | 2025-04-02 |