AccessGUDID - DEVICE: Venus Bulk Fill PLT Refill (J014660447430)

GUDID

Device Identifier (DI) Information

Brand Name: Venus Bulk Fill PLT Refill
Version or Model: 66044743
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 66044743
Company Name: Kulzer GmbH

Primary DI Number: J014660447430
Issuing Agency: HIBCC
Commercial Distribution End Date: August 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 315666321 *Terms of Use

Device Description: Varnish, cavity

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?
35698	Dental cavity varnish	A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LBH	VARNISH, CAVITY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091635	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: 4ee0cd19-6c4c-4822-a5f7-60705a2bd64d
Public Version Date: October 30, 2024
Public Version Number: 5
DI Record Publish Date: September 15, 2016