AccessGUDID - DEVICE: ZIRCONIA POLISHING KIT CA (E2350333B0)

GUDID

Device Identifier (DI) Information

Brand Name: ZIRCONIA POLISHING KIT CA
Version or Model: 0333B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0333B
Company Name: SHOFU DENTAL CORPORATION

Primary DI Number: E2350333B0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 054618202 *Terms of Use

Device Description: Contains DIs: E23506580; E23506650; E23506700; E23506630; E23506680; E23506730; E23506610; E23506660; E23506710

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:	Yes
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?
31833	Dental abrasive point, reusable	A rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHL	Point, Abrasive

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 [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 1 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: eba5511a-f701-4743-aa35-0518c286db31
Public Version Date: October 07, 2022
Public Version Number: 2
DI Record Publish Date: July 20, 2021