AccessGUDID - DEVICE: PANAVIA™ Veneer LC (EKUR004513KA1)

GUDID

Device Identifier (DI) Information

Brand Name: PANAVIA™ Veneer LC
Version or Model: #4513-KA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KURARAY NORITAKE DENTAL INC.

Primary DI Number: EKUR004513KA1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 697119498 *Terms of Use

Device Description: Applicator tip (16G)

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?
62477	Dental composite resin kit	A collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application; it does not include non-resin-based cements nor dental prosthesis. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMA	Cement, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210504	000

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: e3257717-4fe1-47b5-bded-7056c211cfce
Public Version Date: November 15, 2021
Public Version Number: 1
DI Record Publish Date: November 05, 2021