FDA.reportPublic FDA data

Prettau 5 106H13

Primary DI
D800ZRTA106130
Brand
Prettau 5 106H13
Company
ZIRKONZAHN SRL
Model
ZRTA10613
Device description
Content: 1 piece, height: 13 mm
Published
2026-09-18
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

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
D800ZRTA106130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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.

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
false
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
D800ZRTA09010Prettau 5 98H10ZRTA09012026-09-18
D800ZRTA09110Prettau 5 98H14 with stepZRTA09112026-09-18
D800ZRTA09210Prettau 5 98H18 with stepZRTA09212026-09-18
D800ZRTA09310Prettau 5 98H20 with stepZRTA09312026-09-18
D800ZRTA09410Prettau 5 98H12 with stepZRTA09412026-09-18
D800ZRTA09510Prettau 5 98H22 with stepZRTA09512026-09-18
D800ZRTA09620Prettau 5 98H16 with stepZRTA09622026-09-18
D800ZRTA09710Prettau 5 98H25 with stepZRTA09712026-09-18
D800ZRTA106100Prettau 5 106H10ZRTA106102026-09-18
D800ZRTA106110Prettau 5 106H11ZRTA106112026-09-18
D800ZRTA106120Prettau 5 106H12ZRTA106122026-09-18
D800ZRTA106140Prettau 5 106H14ZRTA106142026-09-18
D800ZRTA106150Prettau 5 106H15ZRTA106152026-09-18
D800ZRTA106160Prettau 5 106H16ZRTA106162026-09-18
D800ZRTA106170Prettau 5 106H17ZRTA106172026-09-18
D800ZRTA106180Prettau 5 106H18ZRTA106182026-09-18
D800ZRTA106190Prettau 5 106H19ZRTA106192026-09-18
D800ZRTA106200Prettau 5 106H20ZRTA106202026-09-18
D800ZRTA106210Prettau 5 106H21ZRTA106212026-09-18
D800ZRTA106220Prettau 5 106H22ZRTA106222026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D800ZRTA09010Prettau 5 98H10ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09110Prettau 5 98H14 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09210Prettau 5 98H18 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09310Prettau 5 98H20 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09410Prettau 5 98H12 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09510Prettau 5 98H22 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09620Prettau 5 98H16 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09710Prettau 5 98H25 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106100Prettau 5 106H10ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106110Prettau 5 106H11ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106120Prettau 5 106H12ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106140Prettau 5 106H14ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106150Prettau 5 106H15ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106160Prettau 5 106H16ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106170Prettau 5 106H17ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106180Prettau 5 106H18ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106190Prettau 5 106H19ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106200Prettau 5 106H20ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106210Prettau 5 106H21ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106220Prettau 5 106H22ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106230Prettau 5 106H23ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106240Prettau 5 106H24ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106250Prettau 5 106H25ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106260Prettau 5 106H26ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106270Prettau 5 106H27ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106280Prettau 5 106H28ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106290Prettau 5 106H29ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106300Prettau 5 106H30ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106310Prettau 5 106H31ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106320Prettau 5 106H32ZIRKONZAHN SRLEIH2026-09-18