FDA.report

Refreshing Liquid 3D by Enrico Steger (10 ml)

Primary DI
D800MFAC2001
Brand
Refreshing Liquid 3D by Enrico Steger (10 ml)
Company
ZIRKONZAHN SRL
Model
MFAC2001
Device description
Content: 10 ml For freshening up the ICE Zirconia Stain Colours 3D by Enrico Steger
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
D800MFAC2001PrimaryHIBCC0

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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