FDA.reportPublic FDA data

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Primary DI
06977274260109
Brand
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Company
Changsha Honchon Technology Co., LTD
Model
ST-ML
Published
2024-03-31
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
K221051000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221051000Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankChangsha Honchon Technology Co., Ltd.2022-07-08EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977274260109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977274260109069772742601096977274260109

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, combination-materialA dental material made of a combination of metal, ceramic, and/or synthetic polymer [e.g., polyethylene (PE)] 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
550050296
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977274260253Intraoral ScannerHCE-IS-1302025-08-31
06977274260260Intraoral ScannerHCE-IS-3002025-08-31
06977274260277Intraoral ScannerHCE-IS-5002025-08-31
06977274260284Intraoral ScannerHCE-IS-8002025-08-31
06977274260017Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankHS2024-03-31
06977274260024Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankHT2024-03-31
06977274260031Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankHT-C2024-03-31
06977274260048Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankHT-Plus2024-03-31
06977274260055Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankHTP-C2024-03-31
06977274260062Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankST2024-03-31
06977274260079Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankST-C2024-03-31
06977274260086Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankST-Plus2024-03-31
06977274260093Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankSTP-C2024-03-31
06977274260116Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankSHT2024-03-31
06977274260123Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankSHT-C2024-03-31
06977274260130Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankSHT-ML2024-03-31
06977274260147Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank3D-ML2024-03-31
06977274260154Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank3D-Plus-ML2024-03-31
06977274260161Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank3D-Pro-ML2024-03-31
06977274260178Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank4D-ML2024-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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J011254014040ceraMotion®DENTAURUM GmbH & Co.KGEIH2026-09-25
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J017BLSTKCV20VITA LUMEX® ACVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-09-24
J017BV13BK12CV50VITA VM®13Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-09-24
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J017BVMKSETCV30VITA VMK Master®Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-09-24
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D800ZRTA09010Prettau 5 98H10ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09110Prettau 5 98H14 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09210Prettau 5 98H18 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09310Prettau 5 98H20 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09410Prettau 5 98H12 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09510Prettau 5 98H22 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09620Prettau 5 98H16 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09710Prettau 5 98H25 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106100Prettau 5 106H10ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106110Prettau 5 106H11ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106120Prettau 5 106H12ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106130Prettau 5 106H13ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106140Prettau 5 106H14ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106150Prettau 5 106H15ZIRKONZAHN SRLEIH2026-09-18