FDA.reportPublic FDA data

Ceramill® Zolid

Primary DI
E4947600238
Brand
Ceramill® Zolid
Company
Amann Girrbach AG
Model
760022
Catalog number
760022
Device description
Ceramill Zolid FX Starter Kit
Published
2017-11-17
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
E4947600238PrimaryHIBCC0

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
Kit
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
D800FMAA01030Colour Liquid A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA04030Colour Liquid A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA05030Colour Liquid A4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA06030Colour Liquid B1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA07030Colour Liquid B2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA08030Colour Liquid B3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA09030Colour Liquid B4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA10030Colour Liquid C1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA11030Colour Liquid C2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA12030Colour Liquid C3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA13030Colour Liquid C4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA14030Colour Liquid D2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA15030Colour Liquid D3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA16030Colour Liquid D4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA17030Set Colour Liquid (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA19030Colour Liquid Thinner (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA20030Colour Liquid Stabilizer (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA31020Colour Liquid Prettau A1 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA31030Colour Liquid Prettau A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA32020Colour Liquid Prettau A2 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA32030Colour Liquid Prettau A2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA33020Colour Liquid Prettau A3 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA33030Colour Liquid Prettau A3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA34020Colour Liquid Prettau A3,5 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA34030Colour Liquid Prettau A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA35020Colour Liquid Prettau A4 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA35030Colour Liquid Prettau A4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA36020Colour Liquid Prettau B1 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA36030Colour Liquid Prettau B1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA37020Colour Liquid Prettau B2 (100 ml)ZIRKONZAHN SRLEIH2026-05-28