FDA.report

PRETTAU 3 Dispersive C3 1H22 (3 pieces)

Primary DI
D800ZROC5103C030
Brand
PRETTAU 3 Dispersive C3 1H22 (3 pieces)
Company
ZIRKONZAHN SRL
Model
ZROC5103C03
Device description
Package content: 3 pieces Height: 22 mm Diameter: size 1 Zirconia with particularly high translucency, flexural strength and Gradual-Triplex-Technology: a triple gradient of natural colour, flexural strength and translucency. Suitable for single crowns (monolithic or reduced restorations for ceramic layering).
Published
2023-07-19
Public version status
New
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
D800ZROC5103C030PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

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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