FDA.reportPublic FDA data

DENTADISC ZR

Primary DI
E235DZ9820C20
Brand
DENTADISC ZR
Company
SHOFU DENTAL CORPORATION
Model
DZ9820C2
Catalog number
DZ9820C2
Device description
DentaDisc ZR CAD/CAM DISC 98 x 20mm C2
Published
2026-08-23
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
false

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
K230003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230003000Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankTopzir Biotech Co., Ltd.2023-03-31EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E235DZ9820C20PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
760-736-3277customer-service@shofu.com

Regulatory Flags#

DUNS number
054618202
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E235DZ9812A10DENTADISC ZRDZ9812A1DZ9812A12026-08-23
E235DZ9812A20DENTADISC ZRDZ9812A2DZ9812A22026-08-23
E235DZ9812A30DENTADISC ZRDZ9812A3DZ9812A32026-08-23
E235DZ9812A350DENTADISC ZRDZ9812A35DZ9812A352026-08-23
E235DZ9812B10DENTADISC ZRDZ9812B1DZ9812B12026-08-23
E235DZ9812B20DENTADISC ZRDZ9812B2DZ9812B22026-08-23
E235DZ9812C10DENTADISC ZRDZ9812C1DZ9812C12026-08-23
E235DZ9812C20DENTADISC ZRDZ9812C2DZ9812C22026-08-23
E235DZ9812C30DENTADISC ZRDZ9812C3DZ9812C32026-08-23
E235DZ9812D20DENTADISC ZRDZ9812D2DZ9812D22026-08-23
E235DZ9812D30DENTADISC ZRDZ9812D3DZ9812D32026-08-23
E235DZ9814A10DENTADISC ZRDZ9814A1DZ9814A12026-08-23
E235DZ9814A20DENTADISC ZRDZ9814A2DZ9814A22026-08-23
E235DZ9814A30DENTADISC ZRDZ9814A3DZ9814A32026-08-23
E235DZ9814A350DENTADISC ZRDZ9814A35DZ9814A352026-08-23
E235DZ9814B10DENTADISC ZRDZ9814B1DZ9814B12026-08-23
E235DZ9814B20DENTADISC ZRDZ9814B2DZ9814B22026-08-23
E235DZ9814BL10DENTADISC ZRDZ9814BL1DZ9814BL12026-08-23
E235DZ9814BL20DENTADISC ZRDZ9814BL2DZ9814BL22026-08-23
E235DZ9814BL30DENTADISC ZRDZ9814BL3DZ9814BL32026-08-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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