AccessGUDID - DEVICE: Colour Liquid Prettau® Aquarell B2 (20 ml) (D800FMAC3703)

GUDID

Device Identifier (DI) Information

Brand Name: Colour Liquid Prettau® Aquarell B2 (20 ml)
Version or Model: FMAC3703
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ZIRKONZAHN SRL

Primary DI Number: D800FMAC3703
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 564251911 *Terms of Use

Device Description: Content: 20 ml Colour Liquid for Prettau® zirconia water-based and acid-free for brush and dipping technique Warmer, less greyish colour shades Every brushstroke before sintering is comprehensible through bio pigments Use only in combination with metal-free brushes or metal-free tweezers

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?
17844	Dental articulation paste/solution	A substance intended to characterize the contact relationship between the maxillary and the mandibular teeth during occlusion, and between interproximal surfaces, to help determine the proper seating of full or partial dentures, crowns and bridges, and to program and/or assess progress of orthodontic treatment. It may include one or more substances (e.g., wetting spray, silicone paste, drying liquid that turns into a removable film) and is designed to be applied to the teeth or a restorative prosthesis to show the contact surfaces in situ or on a substrate (e.g., impression material) that displays visible marks when the patient bites. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIH	POWDER, PORCELAIN

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: 0407dba7-3084-4081-b7bf-0c631b6a82c7
Public Version Date: January 23, 2019
Public Version Number: 3
DI Record Publish Date: November 04, 2016