FDA.reportPublic FDA data

Straumann ZOLID-HT preshade

Primary DI
E494760255STM1
Brand
Straumann ZOLID-HT preshade
Company
Amann Girrbach AG
Model
Straumann ZOLID-HT preshade 0 98x12mm
Catalog number
760255-STM
Published
2020-08-13
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
K063511000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063511000CERAMILL ZIAmann Girrbach America, Inc.2007-02-02EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E494760255STM1PrimaryHIBCC0

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
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