Ceramir Crown & Bridge QuikCap

Primary DI
07350052430175
Brand
Ceramir Crown & Bridge QuikCap
Company
Doxa Dental AB
Model
40029
Published
2016-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113040000CERAMIR CROWN & BRIDGEDoxa Dental AB2011-12-28EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350052430175PrimaryGS10
07350052430205Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350052430175073500524301757350052430175
07350052430205073500524302057350052430205

GMDN Terms#

Term, Definition table
TermDefinition
Glass ionomer dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.855.369-2872info@CeramirUS.com

Regulatory Flags#

DUNS number
350486340
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350052430182Ceramir Applicator 240027400272023-06-08
07350052430328Ceramir® Restore QuikCap40038400382020-12-31
07350052430335Ceramir® Restore QuikCap40039400392020-12-31
07350052430397Ceramir® Protect LC Syringe40044400442021-07-11
07350052430403Ceramir® Protect LC Syringe40045400452021-07-11
07350052430151Ceramir Crown & Bridge QuikCap400302016-08-15
07350052430168Ceramir Crown & Bridge QuikCap400282016-08-15
07350052430199Ceramir Crown & Bridge QuikCap400312016-08-15
07350052430236Ceramir Crown & Bridge QuikMix400322017-01-01
07350052430243Ceramir Crown & Bridge QuikMix400332017-01-01
07350052430250Ceramir Crown & Bridge QuikMix400342017-01-01
07350052430281Ceramir Crown & Bridge QuikCap400352017-09-15
07350052430298Ceramir Bioceramic Implant Cement QuikCap40037400372019-03-20
07350052430380Ceramir® Protect LC Syringe40044400442021-07-11
07350052430311Ceramir® Restore QuikCap40039400392020-12-31

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