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Ultrasonic Tip 0.5mm (BUST-05)

FDA UDI

Class I (US FDA UDI)

by BioMTA

Identity

Trade Name
Ultrasonic Tip 0.5mm (BUST-05) FDA UDI
Generic Name
Ultrasonic dental scaling/debridement system handpiece tip, endodontic FDA UDI
Device Name
Used to remove dental calculus. Also, it is used to remove foreign substances in coronal to middle area of the root canal. FDA UDI
Model / Reference
BUST-05 FDA UDI
Description
Used to remove dental calculus. Also, it is used to remove foreign substances in coronal to middle area of the root canal. FDA UDI

Identifiers

Primary DI / UDI-DI
08800027200115 FDA UDI
FDA Product Code
DZP FDA UDI
GMDN Term
Ultrasonic dental scaling/debridement system handpiece tip, endodontic FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4535 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ultrasonic dental scaling/debridement system handpiece tip, endodontic

Ultrasonic Tip 0.5mm (BUST-05) by BioMTA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasonic dental scaling/debridement system handpiece tip, endodontic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BioMTA

Sources (1)

  • FDA UDI e37e2574-664a-4d87-be6d-8ca2871dc031 33 fields · synced Jun 1, 2026