| Primary Device ID | 00990010306653 |
| NIH Device Record Key | ee79a44c-d3e2-4c41-911e-84ee389b8c67 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Comfort-Sonic |
| Version Model Number | UL2214 |
| Catalog Number | K-9 |
| Company DUNS | 244261462 |
| Company Name | Beyes Dental Canada Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00990010306653 [Primary] |
| ELC | Scaler, Ultrasonic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00990010306653]
Moist Heat or Steam Sterilization
[00990010306653]
Moist Heat or Steam Sterilization
[00990010306653]
Moist Heat or Steam Sterilization
[00990010306653]
Moist Heat or Steam Sterilization
[00990010306653]
Moist Heat or Steam Sterilization
[00990010306653]
Moist Heat or Steam Sterilization
[00990010306653]
Moist Heat or Steam Sterilization
[00990010306653]
Moist Heat or Steam Sterilization
[00990010306653]
Moist Heat or Steam Sterilization
[00990010306653]
Moist Heat or Steam Sterilization
[00990010306653]
Moist Heat or Steam Sterilization
[00990010306653]
Moist Heat or Steam Sterilization
[00990010306653]
Moist Heat or Steam Sterilization
[00990010306653]
Moist Heat or Steam Sterilization
[00990010306653]
Moist Heat or Steam Sterilization
[00990010306653]
Moist Heat or Steam Sterilization
[00990010306653]
Moist Heat or Steam Sterilization
[00990010306653]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-29 |
| Device Publish Date | 2024-01-19 |
| 00837699000833 | Comfort-Sonic LED Scaler P6 Plus,Includes 6 tips ( EE1, 2 EG1, EG2, EG4, EP1) |
| 00837699000826 | Comfort-Sonic LED Scalers P9, includes 8 tips ( EE1, EG1, EG4, EG5, EG6, EP1, EP3, EP4D), 1 tip |
| 00837699000840 | COMFORT-SONIC B1, DENTAL ULTRASONIC SCALER, BUILT-IN MODULE |
| 00990010302037 | COMFORT-SONIC B1, DENTAL ULTRASONIC SCALER, BUILT-IN MODULE |
| 00990010302020 | Comfort-Sonic LED Scaler P6 Plus,Includes 6 tips ( EE1, 2 EG1, EG2, EG4, EP1) |
| 00990010302013 | Comfort-Sonic LED Scalers P9, includes 8 tips ( EE1, EG1, EG4, EG5, EG6, EP1, EP3, EP4D), 1 tip |
| 00990010306646 | Woodpecker: GK4 , Gentle pocket cleansing during periodontal treatment; effective cleansing in p |
| 00990010306639 | Woodpecker: GK3, For removal of large areas of supragingival calculus |
| 00990010306622 | Woodpecker: GK2 , For removal of large areas of supragingival calculus |
| 00990010306615 | Woodpecker: GK1, For removal of large areas of calculus |
| 00990010306738 | Woodpecker: GK20 , for “supragingival shoulder” preparation after the completion of the prep |
| 00990010306721 | Woodpecker: EK8, For root canal enlargement and cleaning |
| 00990010306714 | Woodpecker: GK11 , For orthodontic |
| 00990010306707 | Woodpecker: GK7 , Gentle pocket cleansing during periodontal treatment; effective cleansing in p |
| 00990010306691 | Woodpecker: GK6, Gentle pocket cleansing during periodontal treatment; effective cleansing in po |
| 00990010306684 | Woodpecker: GK5, Gentle pocket cleansing during periodontal treatment; effective cleansing in po |
| 00990010306677 | Woodpecker: PC1 , Sickle scaler type for removal of supragingival calculus. The diamond-shaped c |
| 00990010306660 | Woodpecker: GC2, Removal of supragingival calculus, interdental calculus and calculus at the nec |
| 00990010306653 | Woodpecker: GC1 , Quickly removes obstructions and broken instruments in the middle and apical t |