Ultrasonic Tip 0.3mm (BUST-03)

GUDID 08800027200108

Used to remove dental calculus. Also, it is used to remove foreign substances in the middle to apical area of the root canal.

BioMTA

Ultrasonic dental scaling/debridement system handpiece tip, endodontic
Primary Device ID08800027200108
NIH Device Record Keyabd55f48-d0e6-4bd5-9490-c2e951d4d22d
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltrasonic Tip 0.3mm (BUST-03)
Version Model NumberBUST-03
Company DUNS694860083
Company NameBioMTA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800027200108 [Primary]

FDA Product Code

DZPInstrument, Diamond, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization


[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization


[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization


[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization


[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization


[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization


[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization


[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization


[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization


[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization


[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization


[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization


[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization


[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization


[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization


[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization


[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization


[08800027200108]

Liquid Chemical;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-04-10
Device Publish Date2017-09-01

Devices Manufactured by BioMTA

08800027200023 - Smart MTA2024-04-10 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 - SmartMTA2024-04-10 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 - OrthoMTA2024-04-10 OrthoMTA is ideal for orthograde root canal grafting material especially for file separation, crack tooth syndrome, severely inf
08800027200078 - OrthoMTA2024-04-10 OrthoMTA is ideal for orthograde root canal grafting material especially for file separation, crack tooth syndrome, severely inf
08800027200085 - OrhtoMTA Needle Tips2024-04-10 Disposable and bendable and it is compatible with OrthoMTA Carrier.
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.

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