FDA.reportPublic FDA data

ICE Ceramics Dentine C1 (100 g)

Primary DI
D800KEAA10020
Brand
ICE Ceramics Dentine C1 (100 g)
Company
ZIRKONZAHN SRL
Model
KEAA1002
Device description
Content: 100 g
Published
2023-05-25
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
D800KEAA10020PrimaryHIBCC0

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.

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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