AccessGUDID - DEVICE: Quolis 5000 Series Dental Unit (04952195089413)

GUDID

Device Identifier (DI) Information

Brand Name: Quolis 5000 Series Dental Unit
Version or Model: AU-BDS5180
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AU-BDS5180
Company Name: TAKARA BELMONT CORP.

Primary DI Number: 04952195089413
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690540349 *Terms of Use

Device Description: BELMONT QUOLIS 5000 SERIES DENTAL UNIT CUSPIDOR WITHOUT ASSISTANT INSTRUMENTS

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?
34991	Dental delivery system	A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIA	Unit, Operative Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K072273	000

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: 75e8b7c2-acc8-464f-8940-3f1de33774b4
Public Version Date: August 02, 2023
Public Version Number: 2
DI Record Publish Date: June 23, 2022