AccessGUDID - DEVICE: Provicol (E22110751)

GUDID

Device Identifier (DI) Information

Brand Name: Provicol
Version or Model: 1075
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1075
Company Name: VOCO GmbH

Primary DI Number: E22110751
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316699578 *Terms of Use

Device Description: Eugenol-free temporary luting cement with calcium hydroxide. Semi-elastic properties for safe adhesion of the temporary. Calcium hydroxide: supports formation of secondary dentine and is bacteriostatic. Eugenol-free, thus low allergy potential. Ideal before adhesive luting with resin cements, because no inhibition of curing reaction of resin-based filling or luting materials.

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?
46939	Fatty acid dental cement	A non-sterile, non-aqueous substance containing fatty acids typically with a mixture of oxides or hydroxides of zinc, magnesium, and/or calcium, that cures upon the acid/base reaction of its components and is intended to be used in a professional setting for the temporary luting of prefabricated dental crowns and bridges, but may also be used for the temporary filling of small cavities. It is typically available as a two-component device that can be hand mixed or auto-mixed (using a dispenser with mixing nozzle) into a paste. 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 [?]
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
Storage Environment Temperature: between 4 and 23 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: efd3f240-d1bd-47a3-b970-d82b38e35e1f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 31, 2016