| Primary Device ID | 00628504370759 |
| NIH Device Record Key | d9133ada-e863-4303-af96-6cefb6e9cf44 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Comfort-Sonic B1 |
| Version Model Number | UL3300 |
| Company DUNS | 244261462 |
| Company Name | Beyes Dental Canada Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| 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 | 00628504370759 [Primary] |
| ELC | Scaler, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-22 |
| Device Publish Date | 2019-04-12 |
| 00990010312418 - DURAY | 2025-12-23 DURAY EXTRAORAL X-RAY IMAGING SYSTEM |
| 00990010312562 - DURAY | 2025-12-23 DURAY EXTRAORAL X-RAY IMAGING SYSTEM |
| 00990010312579 - DURAY | 2025-12-23 DURAY EXTRAORAL X-RAY IMAGING SYSTEM |
| 00990010312586 - DURAY | 2025-12-23 DURAY EXTRAORAL X-RAY IMAGING SYSTEM |
| 00990010312593 - DURAY | 2025-12-23 DURAY EXTRAORAL X-RAY IMAGING SYSTEM |
| 00990010312609 - DURAY | 2025-12-23 DURAY EXTRAORAL X-RAY IMAGING SYSTEM |
| 00990010306653 - Comfort-Sonic | 2024-01-29 Woodpecker: GC1 , Quickly removes obstructions and broken instruments in the middle and apical thirds of large and straight cana |
| 00990010306660 - Comfort-Sonic | 2024-01-29 Woodpecker: GC2, Removal of supragingival calculus, interdental calculus and calculus at the neck of the teeth |