FDA.reportPublic FDA data

iNK3D

Primary DI
07630503153809
Brand
iNK3D
Company
Estetic Ceram AG
Model
Midnight
Catalog number
138860
Published
2026-03-18
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
K251084000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251084000zirkon; structure; LFU shades, stains and glazesEstetic Ceram AG2025-06-05EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630503153809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630503153809076305031538097630503153809

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.

Regulatory Flags#

DUNS number
448207782
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630503155131priti® perfectglaze extra fluoPPSTGX032026-10-23
07630503155148priti® perfectglaze extra fluoPPSTGX072026-10-23
07630503155155priti® perfectglaze extra fluoPPSTGX252026-10-23
07630503153519iNK3DShade A DF1388292026-03-18
07630503153526iNK3DShade B DF1388302026-03-18
07630503153533iNK3DShade C DF1388312026-03-18
07630503153540iNK3DShade D DF1388322026-03-18
07630503153557iNK3DWhite DF1388332026-03-18
07630503153564iNK3DVanilla DF1388342026-03-18
07630503153571iNK3DBeige DF1388352026-03-18
07630503153588iNK3DMango DF1388362026-03-18
07630503153595iNK3DPeach DF1388372026-03-18
07630503153601iNK3DChampagne DF1388382026-03-18
07630503153618iNK3DWalnut Fluor1388392026-03-18
07630503153625iNK3DKhaki DF1388402026-03-18
07630503153632iNK3DNeut Violet DF1388412026-03-18
07630503153649iNK3DGrey Blue DF1388422026-03-18
07630503153656iNK3DBlue DF1388432026-03-18
07630503153663iNK3DMahogany UNVSL1388442026-03-18
07630503153670iNK3DGrey DF1388452026-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
01694207545069BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423619BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423626BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423633BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423640BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423657BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423664BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423671BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423688BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423695BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423701BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423718BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423725BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423732BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423749BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423756BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423763BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423770BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423787BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423794BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423800BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423817BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423824BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423831BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423848BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423855BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423862BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423879BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423886BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423893BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25