FDA.report

Colour Liquid Prettau® Aquarell Cervical B (20 ml)

Primary DI
D800FMAC7101
Brand
Colour Liquid Prettau® Aquarell Cervical B (20 ml)
Company
ZIRKONZAHN SRL
Model
FMAC7101
Device description
Content: 20 ml Water-based, for acid-free colouring with bio pigments for interdental and cervical areas as well as occlusal fissures. Suitable for Prettau® Zirconia. Use only in combination with metal-free brushes
Published
2016-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EIHPOWDER, PORCELAIN

Product Code Classifications

CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D800FMAC7101PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental articulation paste/solutionA 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.

Sterilization Methods

Method

Contacts

PhoneEmail
+390474066660info@zirkonzahn.com

Regulatory Flags

DUNS number
564251911
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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