FDA.reportPublic FDA data

VINTAGE LD 15G OPAL 60

Primary DI
E235L85950
Brand
VINTAGE LD 15G OPAL 60
Company
SHOFU DENTAL CORPORATION
Model
L8595
Catalog number
L8595
Device description
VINTAGE LD 15G OPAL 60
Published
2021-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K152392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152392000VINTAGE LDShofu Dental Corporation2016-01-08EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E235L85950PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental porcelain/ceramic restoration kitA collection of containers with different shades of porcelain (ceramic based material in powder form) intended to be used in prefabricated and custom-made dental restorations, e.g., artificial teeth on copings, crowns, or bridges. This kit is typically used in the dental laboratory. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)827-5262customer-service@shofu.com

Regulatory Flags#

DUNS number
054618202
Device count
1
Lot or batch
true
Expiration date on label
true

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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06941382296930Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296947Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296954Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
06941382296961Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-09-05
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