| Primary Device ID | 08800011268466 |
| NIH Device Record Key | 4aa66539-6f84-4e2a-9745-e0f542d61ed7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bone Profile Drill |
| Version Model Number | OTBP6000 |
| Company DUNS | 695333960 |
| Company Name | POINTIMPLANT Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Conditional |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800011268466 [Primary] |
| DZA | Drill, Dental, Intraoral |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800011268466]
Moist Heat or Steam Sterilization
[08800011268466]
Moist Heat or Steam Sterilization
[08800011268466]
Moist Heat or Steam Sterilization
[08800011268466]
Moist Heat or Steam Sterilization
[08800011268466]
Moist Heat or Steam Sterilization
[08800011268466]
Moist Heat or Steam Sterilization
[08800011268466]
Moist Heat or Steam Sterilization
[08800011268466]
Moist Heat or Steam Sterilization
[08800011268466]
Moist Heat or Steam Sterilization
[08800011268466]
Moist Heat or Steam Sterilization
[08800011268466]
Moist Heat or Steam Sterilization
[08800011268466]
Moist Heat or Steam Sterilization
[08800011268466]
Moist Heat or Steam Sterilization
[08800011268466]
Moist Heat or Steam Sterilization
[08800011268466]
Moist Heat or Steam Sterilization
[08800011268466]
Moist Heat or Steam Sterilization
[08800011268466]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-28 |
| Device Publish Date | 2025-05-20 |
| 08800011268480 | OTBP7000 |
| 08800011268473 | OTBP6500 |
| 08800011268466 | OTBP6000 |
| 08800011268459 | OTBP5500 |
| 08800011268442 | OTBP5000 |
| 08800011268435 | OTBP4500 |