ELECTROtorque plus plus
GUDID EKAV100187480
This is a medical device.
Kaltenbach & Voigt GmbH
Line-powered dental drilling system Line-powered dental drilling system Line-powered dental drilling system Line-powered dental drilling system Line-powered dental drilling system Line-powered dental drilling system Line-powered dental drilling system Line-powered dental drilling system Line-powered dental drilling system Line-powered dental drilling system Line-powered dental drilling system Line-powered dental drilling system Line-powered dental drilling system Line-powered dental drilling system Line-powered dental drilling system Line-powered dental drilling system Line-powered dental drilling system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system Dental delivery system| Primary Device ID | EKAV100187480 |
| NIH Device Record Key | cd541ca2-b343-4a9e-b31c-bf42148eb351 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ELECTROtorque plus |
| Version Model Number | 1.001.8748 |
| Catalog Number | plus |
| Company DUNS | 332864359 |
| Company Name | Kaltenbach & Voigt 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 | false |
| Lot Batch | false |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EKAV100187480 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103027
FDA Product Code
| EBW | CONTROLLER, FOOT, HANDPIECE AND CORD |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-26 |
Devices Manufactured by Kaltenbach & Voigt GmbH
| EKAV101167860 - Elements 8:1 | 2021-03-15 This is a medical device. |
| EKAV100381670 - SONICflex clean Tip No. 48 | 2021-03-09 This is a medical device. |
| EKAV100729710 - Prophylaxe Set 2003 | 2021-03-09 |
| EKAV100765500 - Prophylaxe Set 2008L/2018 violett | 2021-03-09 |
| EKAV100957450 - SMART LUX Case 619460L | 2021-03-09 |
| EKAV100957460 - SMART Case 619460C | 2021-03-09 |
| EKAV100957640 - PROPHYflex Perio Powder 20gr. | 2021-03-09 |
| EKAV100960480 - EXPERT LUX Case 680465LRN | 2021-03-09 |
Trademark Results [ELECTROtorque plus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ELECTROTORQUE PLUS 75128581 2083703 Live/Registered |
Harnischfeger Technologies, Inc. 1996-06-28 |
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