FDA.report

Zolid

Primary DI
E4947674871
Brand
Zolid
Company
Amann Girrbach AG
Model
Zolid DRS B4 B40 DR
Catalog number
767487
Published
2021-11-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EIHPowder, Porcelain

Product Code Classifications

CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E4947674871PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
+43552363330austria@amanngirrbach.com

Regulatory Flags

DUNS number
300708950
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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
E4947682361Zolid Bion Zolid Bion BL2 98x12 F7682362025-02-25
E4947682391Zolid Bion Zolid Bion BL2 98x18 F7682392025-02-25
E4947682411Zolid Bion Zolid Bion BL2 98x25 F7682412025-02-25
E4947682421Zolid Bion Zolid Bion BL2 98x30 F7682422025-02-25
E4947682521Zolid Bion Zolid Bion BL4 98x12 F7682522025-02-25
E4947682551Zolid Bion Zolid Bion BL4 98x18 F7682552025-02-25
E4947682571Zolid Bion Zolid Bion BL4 98x25 F7682572025-02-25
E4947682581Zolid Bion Zolid Bion BL4 98x30 F7682582025-02-25
E4947682981Zolid Bion Zolid Bion A4 98x30 F7682982025-02-25
E4947683161Zolid Bion Zolid Bion B3 98x12 F7683162025-02-25
E4947683191Zolid Bion Zolid Bion B3 98x18 F7683192025-02-25
E4947683211Zolid Bion Zolid Bion B3 98x25 F7683212025-02-25
E4947683221Zolid Bion Zolid Bion B3 98x30 F7683222025-02-25
E4947683241Zolid Bion Zolid Bion B4 98x12 F7683242025-02-25
E4947683271Zolid Bion Zolid Bion B4 98x18 F7683272025-02-25
E4947683291Zolid Bion Zolid Bion B4 98x25 F7683292025-02-25
E4947683301Zolid Bion Zolid Bion B4 98x30 F7683302025-02-25

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