FDA.reportPublic FDA data

Ultrasonic Tip CM (BUST-CM)

Primary DI
08800027200092
Brand
Ultrasonic Tip CM (BUST-CM)
Company
BioMTA
Model
BUST-CM
Device description
Used to remove dental calculus. Also, it is used to remove foreign substances in the apical foramen of the root canal.
Published
2017-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DZPInstrument, Diamond, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800027200092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800027200092088000272000928800027200092

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement system handpiece tip, endodonticAn insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to fragment and dislodge the debris within the dental pulp for removal during an endodontic procedure; it is not primarily intended for dental cleaning or periodontal therapy. Also referred to as an ultrasonic endodontic file or rasp, it is available in a variety of forms and sizes, and is typically made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Liquid Chemical""]"
Moist Heat or Steam Sterilization;Liquid Chemical

Regulatory Flags#

DUNS number
694860083
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800027200023Smart MTASmMTA-102017-06-13
08800027200030SmartMTASmMTA-022017-06-13
08800027200047RetroMTA(RetroMTA-OrthoMTAII)RM082017-06-19
08800027200054RetroMTA(RetroMTA-OrthoMTAII)RM022017-06-19
08800027200061OrthoMTAOM052017-06-22
08800027200078OrthoMTAOM502017-06-22
08800027200085OrhtoMTA Needle TipsOMN-012017-07-06
08800027200108Ultrasonic Tip 0.3mm (BUST-03)BUST-032017-09-01
08800027200115Ultrasonic Tip 0.5mm (BUST-05)BUST-052017-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630243660995Alpen DiamondsDent4You AGDZP2026-09-04
07630243661237Alpen DiamondsDent4You AGDZP2026-09-04
07630243662470Alpen DiamondsDent4You AGDZP2026-09-04
07630243662494Alpen DiamondsDent4You AGDZP2026-09-04
07630243662517Alpen DiamondsDent4You AGDZP2026-09-04
07630243662531Alpen DiamondsDent4You AGDZP2026-09-04
07630243662555Alpen DiamondsDent4You AGDZP2026-09-04
07630243662579Alpen DiamondsDent4You AGDZP2026-09-04
07630243662593Alpen DiamondsDent4You AGDZP2026-09-04
07630243662616Alpen DiamondsDent4You AGDZP2026-09-04
07630243662630Alpen DiamondsDent4You AGDZP2026-09-04
07630243662654Alpen DiamondsDent4You AGDZP2026-09-04
07630243662678Alpen DiamondsDent4You AGDZP2026-09-04
07630243662692Alpen DiamondsDent4You AGDZP2026-09-04
07630243662715Alpen DiamondsDent4You AGDZP2026-09-04
07630243662739Alpen DiamondsDent4You AGDZP2026-09-04
07630243662753Alpen DiamondsDent4You AGDZP2026-09-04
07630243662777Alpen DiamondsDent4You AGDZP2026-09-04
07630243662791Alpen DiamondsDent4You AGDZP2026-09-04
07630243662814Alpen DiamondsDent4You AGDZP2026-09-04
07630243662838Alpen DiamondsDent4You AGDZP2026-09-04
07630243662852Alpen DiamondsDent4You AGDZP2026-09-04
07630243662876Alpen DiamondsDent4You AGDZP2026-09-04
07630243662890Alpen DiamondsDent4You AGDZP2026-09-04
07630243662913Alpen DiamondsDent4You AGDZP2026-09-04
07630243662937Alpen DiamondsDent4You AGDZP2026-09-04
07630243662951Alpen DiamondsDent4You AGDZP2026-09-04
07630243662975Alpen DiamondsDent4You AGDZP2026-09-04
07630243662999Alpen DiamondsDent4You AGDZP2026-09-04
07630243663019Alpen DiamondsDent4You AGDZP2026-09-04