FDA.reportPublic FDA data

Colour Liquid A3,5 (50 ml)

Primary DI
D800FMAA0402
Brand
Colour Liquid A3,5 (50 ml)
Company
ZIRKONZAHN SRL
Model
FMAA0402
Device description
Content: 50 ml Colour Liquid for Zirconia Translucent and Zirconia Abutments for dipping technique. Our recommendation: Using metal-free tweezers.
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIHPOWDER, PORCELAIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D800FMAA0402PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D800SY16600ZIRKONZAHN.Implant-Planner incl. Bone & Tooth SegmentationSY16602025-09-05
D800SY16700ZIRKONZAHN.Implant-Planner Practice incl. Bone & Tooth SegmentationSY16702025-09-05
D800DSCL9516A010Abro® Basic Multistratum® A1 95H16DSCL9516A012025-04-04
D800DSCL9516A020Abro® Basic Multistratum® A2 95H16DSCL9516A022025-04-04
D800DSCL9516A030Abro® Basic Multistratum® A3 95H16DSCL9516A032025-04-04
D800DSCL9516A040Abro® Basic Multistratum® A4 95H16DSCL9516A042025-04-04
D800DSCL9516A350Abro® Basic Multistratum® A3,5 95H16DSCL9516A352025-04-04
D800DSCL9516B010Abro® Basic Multistratum® B1 95H16DSCL9516B012025-04-04
D800DSCL9516B020Abro® Basic Multistratum® B2 95H16DSCL9516B022025-04-04
D800DSCL9516B030Abro® Basic Multistratum® B3 95H16DSCL9516B032025-04-04
D800DSCL9516B040Abro® Basic Multistratum® B4 95H16DSCL9516B042025-04-04
D800DSCL9516BLE0Abro® Basic Multistratum® Bleach 95H16DSCL9516BLE2025-04-04
D800DSCL9516C010Abro® Basic Multistratum® C1 95H16DSCL9516C012025-04-04
D800DSCL9516C020Abro® Basic Multistratum® C2 95H16DSCL9516C022025-04-04
D800DSCL9516C030Abro® Basic Multistratum® C3 95H16DSCL9516C032025-04-04
D800DSCL9516C040Abro® Basic Multistratum® C4 95H16DSCL9516C042025-04-04
D800DSCL9516D020Abro® Basic Multistratum® D2 95H16DSCL9516D022025-04-04
D800DSCL9516D030Abro® Basic Multistratum® D3 95H16DSCL9516D032025-04-04
D800DSCL9516D040Abro® Basic Multistratum® D4 95H16DSCL9516D042025-04-04
D800DSCL98S16A010Abro® Basic Multistratum® A1 98H16 with stepDSCL98S16A012025-04-04

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