AccessGUDID - DEVICE: Hydrolux by 3D Dental (00817169028024)

GUDID

Device Identifier (DI) Information

Brand Name: Hydrolux by 3D Dental
Version or Model: HP-PB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HP-PB
Company Name: 3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Primary DI Number: 00817169028024
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080194935 *Terms of Use

Device Description: HYDROLUX PUSH BOTTON HANDPIECE

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?
64225	Pneumatic dental power tool system handpiece tip, reusable	A removable endpiece intended to be attached to a pneumatic dental power tool system handpiece for the application of sonic vibrational energy (e.g., at a frequency of 6 kHz) to mechanically fragment and/or cut bone tissue during a variety of dental surgery procedures, or to apply vibration during restoration placement. It is available in a variety of forms (e.g., flat serrated blade, ball head, nail head, or probe-like) and sizes, and is made of metallic or plastic materials; it is not intended to be held directly (i.e., does not include a holder). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFB	Handpiece, Air-Powered, Dental

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: 9e7c0ff5-3c02-420b-a856-bffc6d65314d
Public Version Date: January 26, 2023
Public Version Number: 1
DI Record Publish Date: January 18, 2023