AccessGUDID - DEVICE: HIRO Light Cure Pattern, Modeling and Indexing Resin (D820HIRO0)

GUDID

Device Identifier (DI) Information

Brand Name: HIRO Light Cure Pattern, Modeling and Indexing Resin
Version or Model: One 3 mL Syringe
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HIRO
Company Name: DENALI CORPORATION

Primary DI Number: D820HIRO0
Issuing Agency: HIBCC
Commercial Distribution End Date: January 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 191036107 *Terms of Use

Device Description: Light Cure Pattern, Modeling and Indexing Resin.

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?
16727	Dental prosthesis restorative material, unfilled resin	A material designed to repair dental prostheses that consists of an unfilled polymeric resin. The material works as a bonding agent to provide a strong and long-lasting attachment to the segments of a broken or cracked prosthesis; it typically consists of a single or two-component polymeric (e.g., acrylic) resin that usually becomes a solid polymer when treated with light and/or heat. The material is used in a dentist?s office or dental laboratory to repair fixed dental prostheses and/or partial or total dentures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKO	Denture Preformed (Partially Prefabricated Denture)

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: 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: 83dfed49-a954-4edf-9989-c13af179e1b2
Public Version Date: June 12, 2023
Public Version Number: 3
DI Record Publish Date: January 09, 2018