AccessGUDID - DEVICE: OptraGloss (DVIV701792WW1)

GUDID

Device Identifier (DI) Information

Brand Name: OptraGloss
Version or Model: 701792WW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 701792WW
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DVIV701792WW1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 7
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: OptraGloss Flame PP, OptraGloss Kelch PP, OptraGloss Linse PP, OptraGloss Flame HP, OptraGloss Kelch HP, OptraGloss Linse HP, OptraGloss Spiralradform HP

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:	Yes
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?
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
EHJ	DISK, 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bf97b825-d5d3-495f-8494-81655b62ad0c
Public Version Date: January 29, 2021
Public Version Number: 1
DI Record Publish Date: January 21, 2021