Primary Device ID | 08800027200092 |
NIH Device Record Key | b5306800-e368-409d-8c52-df8245838a52 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ultrasonic Tip CM (BUST-CM) |
Version Model Number | BUST-CM |
Company DUNS | 694860083 |
Company Name | BioMTA |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | 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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08800027200092 [Primary] |
DZP | Instrument, Diamond, Dental |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08800027200092]
Moist Heat or Steam Sterilization;Liquid Chemical
[08800027200092]
Moist Heat or Steam Sterilization;Liquid Chemical
[08800027200092]
Moist Heat or Steam Sterilization;Liquid Chemical
[08800027200092]
Moist Heat or Steam Sterilization;Liquid Chemical
[08800027200092]
Moist Heat or Steam Sterilization;Liquid Chemical
[08800027200092]
Moist Heat or Steam Sterilization;Liquid Chemical
[08800027200092]
Moist Heat or Steam Sterilization;Liquid Chemical
[08800027200092]
Moist Heat or Steam Sterilization;Liquid Chemical
[08800027200092]
Moist Heat or Steam Sterilization;Liquid Chemical
[08800027200092]
Moist Heat or Steam Sterilization;Liquid Chemical
[08800027200092]
Moist Heat or Steam Sterilization;Liquid Chemical
[08800027200092]
Moist Heat or Steam Sterilization;Liquid Chemical
[08800027200092]
Moist Heat or Steam Sterilization;Liquid Chemical
[08800027200092]
Moist Heat or Steam Sterilization;Liquid Chemical
[08800027200092]
Moist Heat or Steam Sterilization;Liquid Chemical
[08800027200092]
Moist Heat or Steam Sterilization;Liquid Chemical
[08800027200092]
Moist Heat or Steam Sterilization;Liquid Chemical
[08800027200092]
Moist Heat or Steam Sterilization;Liquid Chemical
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2024-04-10 |
Device Publish Date | 2017-09-01 |
08800027200023 - Smart MTA | 2024-04-10 SmartMTA is an ideal material for vital pulp therapy and root repair. With a setting time of 150 seconds and no washout, it is i |
08800027200030 - SmartMTA | 2024-04-10 SmartMTA is an ideal material for vital pulp therapy and root repair. With a setting time of 150 seconds and no washout, it is i |
08800027200047 - RetroMTA(RetroMTA-OrthoMTAII) | 2024-04-10 RetroMTA is an ideal material for vital pulp therapy and root repair. Setting is 150 seconds (W/P=1/0.28). There is no heavy met |
08800027200054 - RetroMTA(RetroMTA-OrthoMTAII) | 2024-04-10 RetroMTA is an ideal material for vital pulp therapy and root repair. Setting is 150 seconds (W/P=1/0.28). There is no heavy met |
08800027200061 - OrthoMTA | 2024-04-10 OrthoMTA is ideal for orthograde root canal grafting material especially for file separation, crack tooth syndrome, severely inf |
08800027200078 - OrthoMTA | 2024-04-10 OrthoMTA is ideal for orthograde root canal grafting material especially for file separation, crack tooth syndrome, severely inf |
08800027200085 - OrhtoMTA Needle Tips | 2024-04-10 Disposable and bendable and it is compatible with OrthoMTA Carrier. |
08800027200092 - Ultrasonic Tip CM (BUST-CM) | 2024-04-10Used to remove dental calculus. Also, it is used to remove foreign substances in the apical foramen of the root canal. |
08800027200092 - Ultrasonic Tip CM (BUST-CM) | 2024-04-10 Used to remove dental calculus. Also, it is used to remove foreign substances in the apical foramen of the root canal. |