FDA.reportPublic FDA data

Nacera

Primary DI
EDMC46203000010
Brand
Nacera
Company
DOCERAM medical ceramics GmbH
Model
Hybrid Bleach 2 Disc
Catalog number
4620300001
Device description
Fully polymerized composite with optimized, high-density filler technology. Radiopaque, 8 shades. Flexural strength: 175 MPa (typical value). Modulus of elasticity: 9900 MPa (typical value).
Published
2017-11-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130654000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130654000CRYSTAL ULTRADental Laboratory Milling Supplies, LLC (Dlms)2013-09-24EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDMC46203000010PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height15Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49231925025952RA@nacera.us

Regulatory Flags#

DUNS number
537713567
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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 0M232603024242022-05-16
EDMC32603087870NaceraPearl Shaded 0M232603087872022-05-16
EDMC32613024240NaceraPearl Shaded 0M332613024242022-05-16
EDMC32613087870NaceraPearl Shaded 0M332613087872022-05-16
EDMC32623024240NaceraPearl Shaded A132623024242022-05-16
EDMC32623087870NaceraPearl Shaded A132623087872022-05-16
EDMC32633024240NaceraPearl Shaded A232633024242022-05-16
EDMC32633087870NaceraPearl Shaded A232633087872022-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941382296862Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
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06941382296930Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296947Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296954Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296961Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
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