FDA.reportPublic FDA data

EVADYNE TEMPORARY CROWN AND BRIDGE RESIN

Primary DI
04560128312578
Brand
EVADYNE TEMPORARY CROWN AND BRIDGE RESIN
Company
NEO DENTAL CHEMICAL PRODUCTS CO.,LTD.
Model
―
Device description
Temporary Crown and Bridge Resin
Published
2017-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111666000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111666000EVADYNE TEMPORARY CROWN AND BRIDGE RESINNeodental Chemical Products Co., Ltd.2011-09-07EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560128312578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560128312578045601283125784560128312578

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge resin, temporaryA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
253-946-0814ndi@neodental-intl.com

Regulatory Flags#

DUNS number
691229181
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560128312530VitapexTips Set2016-12-08
04560128312547VitapexRefill2016-12-14
04560128312554VitapexIntro Kit2016-12-14
14560128312629Neo Blue Tips-2021-05-13
04560128312561Cavios―2018-04-16
04560128312585DentalisSet2016-12-05
04560128312592DentalisPowder2016-12-14
04560128312608DentalisLiquid2016-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942480706086FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707618FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707632FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707649FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707724FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707809FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707823FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942480707830FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-21
06942201776305FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788100FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788292FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788391FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788483FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788582FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788773FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788780FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788797FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788971FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789060FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789152FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789169FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789183FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789251FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789350FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789442FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789459FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789541FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789732FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201790028FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480707625FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17