FDA.reportPublic FDA data

N!CE Glass Ceramic Blocks For Amann Girrbach

Primary DI
07630031734921
Brand
N!CE Glass Ceramic Blocks For Amann Girrbach
Company
Institut Straumann AG
Model
Milling Materials
Catalog number
010.7139
Device description
n!ce®, HT D2, C14
Published
2022-04-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

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
07630031734921PrimaryGS10
07630031770912Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031734921076300317349217630031734921
07630031770912076300317709127630031770912

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)448-8168info.usa@straumann.com

Regulatory Flags#

DUNS number
483599259
Device count
5
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630031711366NAPlan Abutments025.2602-042022-12-02
07630031711410NAPlan Abutments025.2612-042022-12-02
07630031711427NAPlan Abutments025.2613-042022-12-02
07630031711465NAPlan Abutments025.2621-042022-12-02
07630031712639NATransfer aids025.4913-042022-12-02
07630031722645NAPlan Abutments048.073V42022-12-02
07630031723000NAConventional impression048.122V42022-12-02
07630031723970NAPlan Abutments048.276V42022-12-02
07630031724021NAPlan Abutments048.283V42022-12-02
07630031724038NAPlan Abutments048.284V42022-12-02
07630031724045NAPlan Abutments048.285V42022-12-02
07630031724052NAPlan Abutments048.286V42022-12-02
07630031724069NAPlan Abutments048.287V42022-12-02
07630031734884N!CE Glass Ceramic Blocks For Amann GirrbachMilling Materials010.71352023-08-24
07630031731012n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70522019-06-18
07630031731029n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70532019-06-18
07630031731050n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70562019-06-18
07630031731067n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70572019-06-18
07630031731081n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70592019-06-18
07630031739704JUVORA Dental Disc, Ceramill PEEK by JUVORABridges (tooth borne)010.41332019-08-23

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EDDI963851DD cubeY® HLDental Direkt GmbHEIH2026-06-02
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EDDI963941DD cubeY® HLDental Direkt GmbHEIH2026-06-02
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EDDI963961DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963971DD cubeY® HLDental Direkt GmbHEIH2026-06-02
D800FMAA01030Colour Liquid A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA04030Colour Liquid A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA05030Colour Liquid A4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA06030Colour Liquid B1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA07030Colour Liquid B2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA08030Colour Liquid B3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA09030Colour Liquid B4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA10030Colour Liquid C1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA11030Colour Liquid C2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA12030Colour Liquid C3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28