AccessGUDID - DEVICE: OptraPol (DIVO6344621)

GUDID

Device Identifier (DI) Information

Brand Name: OptraPol
Version or Model: 634462
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 634462
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO6344621
Issuing Agency: HIBCC
Commercial Distribution End Date: February 10, 2022
Device Count: 8
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: OptraPol Small Flame, OptraPol Large Flame, OptraPol Cup, OptraPol Lens

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?
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: 5cb96ebd-c32e-4dcd-aa8b-9f7d682b21e3
Public Version Date: February 11, 2022
Public Version Number: 2
DI Record Publish Date: August 26, 2020