FDA.reportPublic FDA data

ZIRCONIA BLOCK

Primary DI
06942508837020
Brand
ZIRCONIA BLOCK
Company
Hangzhou IVISTA Medical Devices Co., Ltd.
Model
ST-5M3-D98*20
Published
2026-07-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
K233125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233125000Zirconia BlockHangzhou Ivista Medical Devices Co., Ltd.2024-01-12EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06942508837020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942508837020069425088370206942508837020

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
699364781
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
true
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
06942508837013ZIRCONIA BLOCKST-5M3-D98*182026-07-10
06942508892586ZIRCONIA BLOCK3D-5M3-AG*222026-07-10
06942508892593ZIRCONIA BLOCK3D-5M3-AG*252026-07-10
06976691250007ZIRCONIA BLOCKST-5M3-D98*142026-07-10
06976691250014ZIRCONIA BLOCKST-5M3-D98*162026-07-10
06978951501003ZIRCONIA BLOCK4D-5M3-AG*222026-07-10
06978951501010ZIRCONIA BLOCK4D-5M3-AG*252026-07-10
06978951501027ZIRCONIA BLOCKML-W-D98*102026-07-10
06978951501034ZIRCONIA BLOCKML-W-D98*122026-07-10
06978951501041ZIRCONIA BLOCKML-W-D98*142026-07-10
06978951501058ZIRCONIA BLOCKML-W-D98*162026-07-10
06978951501065ZIRCONIA BLOCKML-W-D98*182026-07-10
06978951501072ZIRCONIA BLOCKML-W-D98*202026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942629805069Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805298Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805526Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805755Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805984Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-22
06942629805090Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805229Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805236Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805243Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805328Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805458Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805465Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805472Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805557Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805571Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805687Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805694Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805700Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805915Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805922Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805939Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629805946Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806011Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806141Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806158Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806165Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806172Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806264Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806387Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21
06942629806394Dental Zirconia BlankHunan Qinghaopuzhong Technology Co., Ltd.EIH2026-07-21