FDA.reportPublic FDA data

MIISEN®

Primary DI
06975801800224
Brand
MIISEN®
Company
Anhui Miisen Intelligence Technology Co., Ltd.
Model
3D-Pro ML-A2 98*12
Device description
Dental Zirconia Block (Model: HTplus, ST, SHT,UT, 3D-Pro) is intended for use with CAD/CAM technology to produce all ceramic dental restorations as prescibed by a dentist. All blanks are processed through dental laboratories or by dental professionals.
Published
2025-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K240912000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240912000Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)Anhui Miisen Intelligence Technology Co., Ltd.2024-05-31EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975801800224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975801800224069758018002246975801800224

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

Regulatory Flags#

DUNS number
406697046
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975801800392MIISEN®3D-Pro ML-BL3 98*122026-01-06
06975801800408MIISEN®3D-Pro ML-BL4 98*122026-01-06
06975801801412MIISEN®3D-Pro ML-A1 98*252026-01-06
06941244515483MIISEN®SHT ML-A1 98*162026-01-05
06975801800217MIISEN®3D-Pro ML-A1 98*12 2026-01-05
06975801800286MIISEN®3D-Pro ML-B3 98*122026-01-05
06975801800293MIISEN®3D-Pro ML-B4 98*122026-01-05
06975801800309MIISEN®3D-Pro ML-C1 98*122026-01-05
06975801800378MIISEN®3D-Pro ML-BL1 98*122026-01-05
06975801807957MIISEN®SHT ML-A1 98*142026-01-05
06975801800231MIISEN®3D-Pro ML-A3 98*122025-12-09
06975801800248MIISEN®3D-Pro ML-A3.5 98*122025-12-09
06975801800255MIISEN®3D-Pro ML-A4 98*122025-12-09
06975801800262MIISEN®3D-Pro ML-B1 98*122025-12-09
06975801800279MIISEN®3D-Pro ML-B2 98*122025-12-09
06975801800316MIISEN®3D-Pro ML-C2 98*122025-12-09
06975801800323MIISEN®3D-Pro ML-C3 98*122025-12-09
06975801800330MIISEN®3D-Pro ML-C4 98*122025-12-09
06975801800347MIISEN®3D-Pro ML-D2 98*122025-12-09
06975801800354MIISEN®3D-Pro ML-D3 98*122025-12-09

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