FDA.reportPublic FDA data

Estar-ZE

Primary DI
08800209338865
Brand
Estar-ZE
Company
Osstem Implant Co.,Ltd.
Model
ZEHTA2014M
Published
2024-12-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242521000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242521000Estar-ZEOsstem Implant Co., Ltd.2024-11-20EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800209338865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800209338865088002093388658800209338865

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made dental crown, ceramicA device made totally of ceramic material, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.

Regulatory Flags#

DUNS number
696467699
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
08800000995809N1N12026-08-27
08800040673866HySil Impression Materials (Heavy, Mono, and Bite)ESS380H2020-11-17
08800040673873HySil Impression Materials (Heavy, Mono, and Bite)ESS380M2020-11-17
08800040673880HySil Impression MaterialsESS400P2020-11-17
08800040673897HySil Impression Materials (Heavy, Mono, and Bite)ESS50B2020-11-17
08800040673903HySil Impression MaterialsESS50EL2020-11-17
08800040673910HySil Impression MaterialsESS50HB2020-11-17
08800040673927HySil Super Fast Impression MaterialsESS50HF2020-11-17
08800040673934HySil Super Fast Impression MaterialsESS50HFB2020-11-17
08800040673941HySil Super Fast Impression MaterialsESS50HFD2020-11-17
08800040673958HySil Impression MaterialsESS50H2020-11-17
08800040673965HySil Impression MaterialsESS50LB2020-11-17
08800040673972HySil Super Fast Impression MaterialsESS50LF2020-11-17
08800040673989HySil Super Fast Impression MaterialsESS50LFB2020-11-17
08800040673996HySil Super Fast Impression MaterialsESS50LFD2020-11-17
08800040674009HySil Impression MaterialsESS50L2020-11-17
08800040674016HySil Impression MaterialsESS50MB2020-11-17
08800040674023HySil Super Fast Impression MaterialsESS50MF2020-11-17
08800040674030HySil Super Fast Impression MaterialsESS50MFB2020-11-17
08800040674047HySil Super Fast Impression MaterialsESS50MFD2020-11-17

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