Friendo
GUDID 08800017900070
Lightest cordless warm vertical condensation device Effectively liquefies and condenses root canal filling materials 3 adjustable temperature settings Color-coded pen tips available in various sizes (XF, F, FM, M, ML) Excellent apical control over lateral and complicated root canals
DXM CO., LTD
Root canal obturation kit| Primary Device ID | 08800017900070 |
| NIH Device Record Key | f95b1c73-9c53-4903-8c3e-7da9f29dfe01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Friendo |
| Version Model Number | Friendo |
| Company DUNS | 688797315 |
| Company Name | DXM CO., LTD |
| 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 | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 60 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800017900070 [Primary] |
FDA Product Code
| EKR | Plugger, Root Canal, Endodontic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800017900070]
Moist Heat or Steam Sterilization
[08800017900070]
Moist Heat or Steam Sterilization
[08800017900070]
Moist Heat or Steam Sterilization
[08800017900070]
Moist Heat or Steam Sterilization
[08800017900070]
Moist Heat or Steam Sterilization
[08800017900070]
Moist Heat or Steam Sterilization
[08800017900070]
Moist Heat or Steam Sterilization
[08800017900070]
Moist Heat or Steam Sterilization
[08800017900070]
Moist Heat or Steam Sterilization
[08800017900070]
Moist Heat or Steam Sterilization
[08800017900070]
Moist Heat or Steam Sterilization
[08800017900070]
Moist Heat or Steam Sterilization
[08800017900070]
Moist Heat or Steam Sterilization
[08800017900070]
Moist Heat or Steam Sterilization
[08800017900070]
Moist Heat or Steam Sterilization
[08800017900070]
Moist Heat or Steam Sterilization
[08800017900070]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-27 |
| Device Publish Date | 2023-06-19 |
Devices Manufactured by DXM CO., LTD
| 08800017900223 - DX-Condenser | 2024-07-23 Nickel titanium and a stainless-steel end. Can be used in any common obturation technique, including warm and cold condensation. |
| 08800017901930 - C-Warmer | 2024-07-23 C-Warmer is designed to enhance both the doctor' and the patiends'. A themostatically-controlled cartridge/composite warmer sign |
| 08800017902050 - Disposable Impression Bite Tray | 2024-06-19 Disposable Impression Bite Trays with stainless-steel edge frames used to make an impression of a patient's teeth or alveolar pr |
| 08800017902067 - Disposable Impression Bite Tray | 2024-06-19 Disposable Impression Bite Trays with stainless-steel edge frames used to make an impression of a patient's teeth or alveolar pr |
| 08800017902098 - Disposable Impression Bite Tray | 2024-06-19 Disposable Impression Bite Trays with stainless-steel edge frames used to make an impression of a patient's teeth or alveolar pr |
| 08800017900292 - DX-Mixer | 2024-06-12 The dental impression material mixed with a base and a catalyst is used in a dental clinic rapidly to obtain the dental impressi |
| 08800017900285 - DX-Mixer | 2024-06-12 The dental impression material mixed with a base and a catalyst is used in a dental clinic rapidly to obtain the dental impressi |
| 08800017900414 - DX-Mixer | 2024-06-12 The dental impression material mixed with a base and a catalyst is used in a dental clinic rapidly to obtain the dental impressi |
Trademark Results [Friendo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FRIENDO 88935810 not registered Live/Pending |
Cultivated California, LLC 2020-05-27 |
 FRIENDO 79182034 not registered Dead/Abandoned |
Friendo Events AB, att. Viktor Gällström Organizational number: 559000-9444 2015-09-02 |
 FRIENDO 78237214 not registered Dead/Abandoned |
BELL AND NEWTON COMPANY LIMITED 2003-04-14 |
 FRIENDO 77271706 3542622 Dead/Cancelled |
Bell & Newton Co. Limited 2007-09-05 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.