| Primary Device ID | 08800313230475 |
| NIH Device Record Key | b1437974-8a20-432c-ac8b-14b4f39f31a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SQ AXEL Step Drill |
| Version Model Number | DSASTD4208 |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800313230475 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800313230475]
Moist Heat or Steam Sterilization
[08800313230475]
Moist Heat or Steam Sterilization
[08800313230475]
Moist Heat or Steam Sterilization
[08800313230475]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-16 |
| Device Publish Date | 2026-03-06 |
| 08800313237108 | SQ AXEL Step Drill (DSASTD2420) |
| 08800313233094 | SQ AXEL Step Drill (DSASTD5020) |
| 08800313233087 | SQ AXEL Step Drill (DSASTD4620) |
| 08800313233070 | SQ AXEL Step Drill (DSASTD4220) |
| 08800313233063 | SQ AXEL Step Drill (DSASTD3820) |
| 08800313230628 | SQ AXEL Step Drill (DSASTD5012) |
| 08800313230611 | SQ AXEL Step Drill (DSASTD5010) |
| 08800313230598 | SQ AXEL Step Drill (DSASTD4612) |
| 08800313230581 | SQ AXEL Step Drill (DSASTD4610) |
| 08800313230567 | SQ AXEL Step Drill (DSASTD4212) |
| 08800313230550 | SQ AXEL Step Drill (DSASTD4210) |
| 08800313230536 | SQ AXEL Step Drill (DSASTD3812) |
| 08800313230529 | SQ AXEL Step Drill (DSASTD3810) |
| 08800313230512 | SQ AXEL Step Drill (DSASTD5008) |
| 08800313230505 | SQ AXEL Step Drill (DSASTD5007) |
| 08800313230499 | SQ AXEL Step Drill (DSASTD4608) |
| 08800313230482 | SQ AXEL Step Drill (DSASTD4607) |
| 08800313230475 | SQ AXEL Step Drill (DSASTD4208) |
| 08800313230468 | SQ AXEL Step Drill (DSASTD4207) |
| 08800313230451 | SQ AXEL Step Drill (DSASTD3808) |
| 08800313230444 | SQ AXEL Step Drill (DSASTD3807) |
| 08800313230437 | SQ AXEL Step Drill (DSASTD2414) |