FDA.reportPublic FDA data

Ceramill

Primary DI
E4947610431
Brand
Ceramill
Company
Amann Girrbach AG
Model
Ceramill A-Temp ML A2/A3 71x14
Catalog number
761043
Published
2019-12-04
Public version status
Update
Distribution status
Not 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
EBGCrown And Bridge, Temporary, Resin
POWCrown And Bridge, Long-Term Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2
POWCrown And Bridge, Long-Term Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191843000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191843000Ceramill A-TempAmann Girrbach AG2019-10-04EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E4947610431PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge, temporaryA prosthetic dental device used to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+435523623330austria@amanngirrbach.com

Regulatory Flags#

DUNS number
300708950
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E4947610871Ceramill A-SplintCeramill A-Splint 98x14/107610872026-01-21
E4947610881Ceramill A-SplintCeramill A-Splint 98x16/107610882026-01-21
E4947610891Ceramill A-SplintCeramill A-Splint 98x20/107610892026-01-21
E4947604691Ceramill® LiquidLiquid Set update7604692020-10-15
E4947604301Ceramill® LiquidLiquid A17604302016-06-30
E4947604321Ceramill® LiquidLiquid A27604322016-06-30
E4947604331Ceramill® LiquidLiquid A37604332016-06-30
E4947604341Ceramill® LiquidLiquid A3,57604342016-06-30
E4947604351Ceramill® LiquidLiquid A47604352016-06-30
E4947604361Ceramill® LiquidLiquid B17604362016-06-30
E4947604381Ceramill® LiquidLiquid B37604382016-06-30
E4947604391Ceramill® LiquidLiquid B47604392016-06-30
E4947604401Ceramill® LiquidLiquid C17604402016-06-30
E4947604421Ceramill® LiquidLiquid C27604422016-06-30
E4947604431Ceramill® LiquidLiquid C37604432016-06-30
E4947604441Ceramill® LiquidLiquid C47604442016-06-30
E4947604451Ceramill® LiquidLiquid D27604452016-06-30
E4947604461Ceramill® LiquidLiquid D37604462016-06-30
E4947604471Ceramill® LiquidLiquid D47604472016-06-30
E4947604491Ceramill® LiquidDimmer Liquid Refill7604492016-06-30

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