| Primary Device ID | 00860014936616 |
| NIH Device Record Key | 641a864e-4ca3-493a-a1b5-43a82c85ffaa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Universal Shapers |
| Version Model Number | Cortical Release Drill CR 4.2mm X 5mm |
| Company DUNS | 104090226 |
| Company Name | UNIVERSAL SHAPERS LLC |
| 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860014936616 [Primary] |
| DZA | Drill, Dental, Intraoral |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00860014936616]
Moist Heat or Steam Sterilization
[00860014936616]
Moist Heat or Steam Sterilization
[00860014936616]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-16 |
| Device Publish Date | 2026-02-06 |
| 00860014936647 | A specialized dental instrument used for bone profiling, shaping, and sculpting in implant denti |
| 00860014936630 | A specialized dental instrument used for bone profiling, shaping, and sculpting in implant denti |
| 00860014936616 | A specialized surgical instrument used in dentistry, particularly during implant placement or gu |
| 00860014936609 | A specialized surgical instrument used in dentistry, particularly during implant placement or gu |