| Primary Device ID | D928P0112810 |
| NIH Device Record Key | 9d0e8cbf-f600-461b-8656-4d5188a8bba2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | X-NAV, HANDPIECE CALIBRATION BIT LATCH, SZ-75 |
| Version Model Number | P011281 |
| Company DUNS | 183854322 |
| Company Name | W.H. Holden, Inc. |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D928P0112810 [Primary] |
| DZA | Drill, Dental, Intraoral |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D928P0112810]
Moist Heat or Steam Sterilization
[D928P0112810]
Moist Heat or Steam Sterilization
[D928P0112810]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-23 |
| Device Publish Date | 2025-01-15 |
| D928P0112810 - X-NAV, HANDPIECE CALIBRATION BIT LATCH, SZ-75 | 2025-01-23 |
| D928P0112810 - X-NAV, HANDPIECE CALIBRATION BIT LATCH, SZ-75 | 2025-01-23 |
| D9283001080 - SCISSORS OPERATING 6" CRV. S/S TC | 2024-12-27 |
| D9283001090 - SCISSORS MAYO 5 1/2" STRAIGHT TC | 2024-12-27 |
| D9283001100 - SCISSORS MAYO 5 1/2" CURVED TC | 2024-12-27 |
| D9283001110 - SCISSORS MAYO 6 3/4" STRAIGHT TC | 2024-12-27 |
| D9283001120 - SCISSORS MAYO 6 3/4" CURVED TC | 2024-12-27 |
| D9283001150 - SCISSORS METZENBAUM 5 3/4" STRAIGHT BLUNT TC | 2024-12-27 |
| D9283001160 - SCISSORS METZ 5 3/4" CURVED TC | 2024-12-27 |