FDA.reportPublic FDA data

Nacera

Primary DI
EDMC4000LQ70500
Brand
Nacera
Company
DOCERAM medical ceramics GmbH
Model
Classic Liquid Body A1
Catalog number
4000LQ7050
Device description
Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium oxide, especially for Nacera® Pearl 1. 16 + 2 shades, 4 effect liquids, balancer, diluting.
Published
2016-12-20
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
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092020000AADVA ZR COLORING LIQUIDGC America, Inc.2009-09-29EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDMC4000LQ70500PrimaryHIBCC0

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
Total Volume50Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 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
D800ZRTA09010Prettau 5 98H10ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09110Prettau 5 98H14 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09210Prettau 5 98H18 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09310Prettau 5 98H20 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09410Prettau 5 98H12 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09510Prettau 5 98H22 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09620Prettau 5 98H16 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09710Prettau 5 98H25 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106100Prettau 5 106H10ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106110Prettau 5 106H11ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106120Prettau 5 106H12ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106130Prettau 5 106H13ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106140Prettau 5 106H14ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106150Prettau 5 106H15ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106160Prettau 5 106H16ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106170Prettau 5 106H17ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106180Prettau 5 106H18ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106190Prettau 5 106H19ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106200Prettau 5 106H20ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106210Prettau 5 106H21ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106220Prettau 5 106H22ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106230Prettau 5 106H23ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106240Prettau 5 106H24ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106250Prettau 5 106H25ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106260Prettau 5 106H26ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106270Prettau 5 106H27ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106280Prettau 5 106H28ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106290Prettau 5 106H29ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106300Prettau 5 106H30ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106310Prettau 5 106H31ZIRKONZAHN SRLEIH2026-09-18