FDA.reportPublic FDA data

Ceramill® Zolid

Primary DI
E4947601271
Brand
Ceramill® Zolid
Company
Amann Girrbach AG
Model
Zolid fx 71 XL
Catalog number
760127
Published
2016-06-30
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
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152383000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152383000Ceramill Zolid FXEmergo Europe Consulting2015-09-21EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E4947601271PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+43552362333105austria@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
Donation ID number
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
06942508892586ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06942508892593ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06976691250007ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06976691250014ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501003ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501010ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501027ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501034ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501041ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501058ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501065ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501072ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
07615208543582IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543599IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543674IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543681IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543698IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543704IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543711IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543728IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543735IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543858IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543865IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543872IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543889IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543896IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543902IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543919IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544039IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544046IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07