FDA.report

Nacera

Primary DI
EDMC3210WN20990
Brand
Nacera
Company
DOCERAM medical ceramics GmbH
Model
Pearl 1 Zirkonzahn 95
Catalog number
3210WN2099
Device description
3Y-TZP zirconium dioxide, pre-sintered white-fired condition. Translucent, white. Suitable for single crowns and/or bridges consisting of up to 16 units. 4-point bending strength: 1200 MPa (typical value)
Published
2016-12-21
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

Related Records

Contact Domains

Product Codes

CodeName
EIHPowder, Porcelain

Product Code Classifications

CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EDMC3210WN20990PrimaryHIBCC0

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.

Device Sizes

TypeValueUnit
Height22Millimeter
Outer Diameter95Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius50 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+49231925025952RA@nacera.us

Regulatory Flags

DUNS number
537713567
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
false
Expiration date on label
true
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 DIBrandModelCatalogPublished
EDMC35593030960NaceraPearl Natural Stellar white35593030962020-11-12
EDMC35593039130NaceraPearl Natural Stellar white35593039132020-11-12
EDMC35603030960NaceraPearl Natural 0M235603030962020-11-12
EDMC35603039130NaceraPearl Natural 0M235603039132020-11-12
EDMC35623030960NaceraPearl Natural A135623030962020-11-12
EDMC35623039130NaceraPearl Natural A135623039132020-11-12
EDMC35633030960NaceraPearl Natural A235633030962020-11-12
EDMC35633039130NaceraPearl Natural A235633039132020-11-12
EDMC35643030960NaceraPearl Natural A335643030962020-11-12
EDMC35643039130NaceraPearl Natural A335643039132020-11-12
EDMC35653030960NaceraPearl Natural A3,535653030962020-11-12
EDMC35653039130NaceraPearl Natural A3,535653039132020-11-12
EDMC32603024240NaceraPearl Shaded 0M2 32603024242022-05-16
EDMC32603087870NaceraPearl Shaded 0M2 32603087872022-05-16
EDMC32613024240NaceraPearl Shaded 0M3 32613024242022-05-16
EDMC32613087870NaceraPearl Shaded 0M3 32613087872022-05-16
EDMC32623024240NaceraPearl Shaded A132623024242022-05-16
EDMC32623087870NaceraPearl Shaded A132623087872022-05-16
EDMC32633024240NaceraPearl Shaded A2 32633024242022-05-16
EDMC32633087870NaceraPearl Shaded A2 32633087872022-05-16

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06941382286740Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286757Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286764Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286771Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286788Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286795Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286801Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286818Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286825Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286832Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286849Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286856Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286863Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286870Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286887Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286894Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286900Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286917Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286924Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286931Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286948Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286955Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286962Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286979Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286986Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286993Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382287006Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382287013Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382287020Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382287037Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20