AccessGUDID - DEVICE: PROVIL NOVO L. F CD2 1X(2X50ML) (J014660082900)

GUDID

Device Identifier (DI) Information

Brand Name: PROVIL NOVO L. F CD2 1X(2X50ML)
Version or Model: 66008290
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 66008290
Company Name: Kulzer GmbH

Primary DI Number: J014660082900
Issuing Agency: HIBCC
Commercial Distribution End Date: September 09, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 315666321 *Terms of Use

Device Description: Material, Impression

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?
35864	Polyether dental impression material	An elastomeric, polyether-based material capable of reacting to form a rubber-like substance used to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELW	MATERIAL, IMPRESSION

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: ade65a77-5640-42e6-9dbf-0298c0dfd7fd
Public Version Date: September 10, 2025
Public Version Number: 3
DI Record Publish Date: September 09, 2024