FDA.reportPublic FDA data

MiYO Esthetic System

Primary DI
00817340026146
Brand
MiYO Esthetic System
Company
JENSEN INDUSTRIES INC.
Model
MiYO 3D Trans Shade 11 Fluor Paste 4g
Catalog number
0075
Published
2026-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111743000THE INSYNC CERAMIC SYSTEMJensen Industries, Inc.2011-09-14EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817340026146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817340026146008173400261468173400261460817340026146

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

Regulatory Flags#

DUNS number
060018587
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817340026184MiYO Esthetic SystemMiYO High Performance Glaze Paste 6g00152026-03-27
00817340026177MiYO Esthetic SystemMiYO High Performance Glaze Paste 3g00142026-03-09
00817340026047MiYO Esthetic SystemMiYO 3D Trans Shade 1 Fluor Paste 4g00652026-02-21
00817340026054MiYO Esthetic SystemMiYO 3D Trans Shade 2 Fluor Paste 4g00662026-02-21
00817340026061MiYO Esthetic SystemMiYO 3D Trans Shade 3 Fluor Paste 4g00672026-02-21
00817340026078MiYO Esthetic SystemMiYO 3D Trans Shade 4 Fluor Paste 4g00682026-02-21
00817340026085MiYO Esthetic SystemMiYO 3D Trans Shade 5 Fluor Paste 4g00692026-02-21
00817340026092MiYO Esthetic SystemMiYO 3D Trans Shade 6 Fluor Paste 4g00702026-02-21
00817340026108MiYO Esthetic SystemMiYO 3D Trans Shade 7 Fluor Paste 4g00712026-02-21
00817340026115MiYO Esthetic SystemMiYO 3D Trans Shade 8 Fluor Paste 4g00722026-02-21
00817340026122MiYO Esthetic SystemMiYO 3D Trans Shade 9 Fluor Paste 4g00732026-02-21
00817340026139MiYO Esthetic SystemMiYO 3D Trans Shade 10 Fluor Paste 4g00742026-02-21
00817340026153MiYO Esthetic SystemMiYO 3D Esthetic System Core KitMI9672026-02-21
00817340026160MiYO Esthetic SystemMiYO 3D Esthetic System Essential KitMI9682026-02-21
00817340026016MiYO Esthetic SystemMiYO Hi Fusing Gingival Structure Orchid Paste 4g09602026-02-12
00817340026023MiYO Esthetic SystemMiYO Hi Fusing Gingival Structure Frost Paste 4g09622026-02-12
00817340026030MiYO Esthetic SystemMiYO Hi Fusing Gingival Structure Rouge Paste 4g09612026-02-12
00817340023572Jensen XT ZirconiaJensen XT TRAN Zr Mono A1 14mm Frame 2pk550182020-05-04
00817340023589Jensen XT ZirconiaJensen XT TRAN Zr Mono A2 14mm Frame 2pk550192020-05-04
00817340023602Jensen XT ZirconiaJensen XT TRAN Zr Mono A3.5 14mm Frame 2pk550212020-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06976581410009Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410016Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410023Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410030Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410047Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410054Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410061Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410078Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
EDDI963011DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963051DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963061DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963071DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963081DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963091DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963161DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963171DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963431DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963441DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963451DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963821DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963831DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963841DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963851DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963861DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963941DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963951DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963961DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963971DD cubeY® HLDental Direkt GmbHEIH2026-06-02
D800FMAA01030Colour Liquid A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA04030Colour Liquid A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28