AccessGUDID - DEVICE: Polibond 30 ml (D800CPAD01010)

GUDID

Device Identifier (DI) Information

Brand Name: Polibond 30 ml
Version or Model: CPAD0101
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ZIRKONZAHN SRL

Primary DI Number: D800CPAD01010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 564251911 *Terms of Use

Device Description: Content: Liquid for bonding Zirkonzahn Abro Basic Mono, Abro Basic Multistratum and Denture Gingiva Basic Mono resins as well as for polishing Zirkonzahn Multistratum Flexible and Temp Premium Flexible resins.

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?
63626	Dental prosthesis-component adhesive	A non-sterile adhesive material (e.g., self- or light-cured polymer composite) intended to be used to bond together components of a restorative dental prosthesis [e.g., crown, removable denture] by functioning as a glue between metal, synthetic, and/or ceramic materials; it is not intended to bond prosthetic devices to patient tissues (e.g., oral mucosa, teeth). Dedicated disposable devices associated with application [e.g., brush, mixing tip] may be included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBI	RESIN, DENTURE, RELINING, REPAIRING, REBASING

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 94c25318-f35b-4234-9ce6-b5e029b6e250
Public Version Date: October 09, 2023
Public Version Number: 1
DI Record Publish Date: September 29, 2023