| Primary Device ID | 08800000995755 |
| NIH Device Record Key | 7007dc97-6040-4f53-b4ba-8daa8d398d53 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Osstem Implant Co.,Ltd. |
| Version Model Number | BeauTis White Light |
| Company DUNS | 694893867 |
| Company Name | Osstem Implant 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800000995755 [Primary] |
| EEG | Heat Source For Bleaching Teeth |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-08 |
| Device Publish Date | 2022-11-30 |
| 08800000995762 | The BeauTis Light S is a teeth whitening lamp that emits visible light to discolored teeth arter |
| 08800000995755 | The BeauTis White Light is a teeth whitening lamp that emits visible light to discolored teeth a |
| 08800000995656 | The intraoral camera with a B applied Part is intended to provide a dentist with the ability to |
| 08800000995649 | This device is an oral camera device that can be magnified in the light of the inside of the mou |