FDA.reportPublic FDA data

Zirconia Translucent Plus 98H14 with step

Primary DI
D800ZRAI0911
Brand
Zirconia Translucent Plus 98H14 with step
Company
ZIRKONZAHN SRL
Model
ZRAI0911
Device description
Content: 1 piece Height: 14 mm With step
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
D800ZRAI0911PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental bridge, ceramicA custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of ceramic/porcelain material and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.

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
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
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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