AccessGUDID - DEVICE: Ultrasonic Tip 0.3mm (BUST-03) (08800027200108)

GUDID

Device Identifier (DI) Information

Brand Name: Ultrasonic Tip 0.3mm (BUST-03)
Version or Model: BUST-03
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BioMTA

Primary DI Number: 08800027200108
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 694860083 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46035	Ultrasonic dental scaling/debridement system handpiece tip, endodontic	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZP	Instrument, Diamond, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Liquid Chemical
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: abd55f48-d0e6-4bd5-9490-c2e951d4d22d
Public Version Date: April 10, 2024
Public Version Number: 4
DI Record Publish Date: September 01, 2017