AccessGUDID - DEVICE: Young (00302732961063)

GUDID

Device Identifier (DI) Information

Brand Name: Young
Version or Model: 296106
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 296106
Company Name: YOUNG DENTAL MANUFACTURING I, LLC

Primary DI Number: 00302732961063
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006309355 *Terms of Use

Device Description: Young Handpiece Adapter for Disposable Prophy Angles, E-type, Low Speed Attachment

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):	Yes
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?
45420	Dental laboratory power tool system	An assembly of devices intended to be used in a dental laboratory to bore/cut/grind dental fixtures, appliances, and materials for their preparation or repair. It typically consists of a drilling handpiece, a compact mains electricity (AC-powered) motor, an enclosed and flexible spinning cable (e.g., a Bowden cable), and a variety of dental power tool attachments to hold the active instruments (e.g., drills, burs, grind wheels). The spinning cable provides power to the handpiece from the electric motor which is placed distant from the site of operation, providing additional protection from exposure to electrical current. The system is typically combined with various speed controllers.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFB	Handpiece, air-powered, dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K881985	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
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: af32ccb6-70e9-4b36-a70e-bbc663ab7d81
Public Version Date: October 24, 2022
Public Version Number: 1
DI Record Publish Date: October 16, 2022