| Primary Device ID | J021063681001 |
| NIH Device Record Key | 410d36d3-80aa-4627-84d9-03a3eb2614cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Scaler Tip 3E |
| Version Model Number | 06368100 |
| Company DUNS | 300238441 |
| Company Name | W & H Dentalwerk Bürmoos GmbH |
| 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 | true |
| 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 |
|---|---|
| HIBCC | J021063681001 [Primary] |
| ELC | Scaler, Ultrasonic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[J021063681001]
Moist Heat or Steam Sterilization
[J021063681001]
Moist Heat or Steam Sterilization
[J021063681001]
Moist Heat or Steam Sterilization
[J021063681001]
Moist Heat or Steam Sterilization
[J021063681001]
Moist Heat or Steam Sterilization
[J021063681001]
Moist Heat or Steam Sterilization
[J021063681001]
Moist Heat or Steam Sterilization
[J021063681001]
Moist Heat or Steam Sterilization
[J021063681001]
Moist Heat or Steam Sterilization
[J021063681001]
Moist Heat or Steam Sterilization
[J021063681001]
Moist Heat or Steam Sterilization
[J021063681001]
Moist Heat or Steam Sterilization
[J021063681001]
Moist Heat or Steam Sterilization
[J021063681001]
Moist Heat or Steam Sterilization
[J021063681001]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-27 |
| Device Publish Date | 2023-07-19 |
| J021305030001 - Piezomed Pro Accessory | 2025-09-30 Instrument MP1-S |
| J021305030011 - Piezomed Pro Accessory | 2025-09-30 Instrument MR1-S |
| J021305030021 - Piezomed Pro Accessory | 2025-09-30 Instrument MR2-S |
| J021305030031 - Piezomed Pro Accessory | 2025-09-30 Instrument MR3-S |
| J021305030041 - Piezomed Pro Accessory | 2025-09-30 Instrument MR4-S |
| J021305030051 - Piezomed Pro Accessory | 2025-09-30 Instrument MR5-S |
| J021305030061 - Piezomed Pro Accessory | 2025-09-30 Instrument MR6-S |
| J021305030071 - Piezomed Pro Accessory | 2025-09-30 Instrument MS1-S |