FDA.reportPublic FDA data

Dental Lithium Disilicate Glass Ceramic

Primary DI
06978137013085
Brand
Dental Lithium Disilicate Glass Ceramic
Company
Liaoning Rachcera Material Technology Co.,Ltd.
Model
P-HO-2 W(D13×10mm)
Published
2025-01-20
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
K242740000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242740000Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)Liaoning Rachcera Material Technology Co., Ltd.2024-12-05EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06978137013085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978137013085069781370130856978137013085

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
616321064
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
06978137010015Dental Lithium Disilicate Glass CeramicHT-0M1 RC(18×15×13mm)2025-01-20
06978137010022Dental Lithium Disilicate Glass CeramicHT-0M2 RC(18×15×13mm)2025-01-20
06978137010039Dental Lithium Disilicate Glass CeramicHT-0M3 RC(18×15×13mm)2025-01-20
06978137010046Dental Lithium Disilicate Glass CeramicHT-A1 RC(18×15×13mm)2025-01-20
06978137010053Dental Lithium Disilicate Glass CeramicHT-A2 RC(18×15×13mm) 2025-01-20
06978137010060Dental Lithium Disilicate Glass CeramicHT-A3 RC(18×15×13mm)2025-01-20
06978137010077Dental Lithium Disilicate Glass CeramicHT-A3.5 RC(18×15×13mm)2025-01-20
06978137010084Dental Lithium Disilicate Glass CeramicHT-A4 RC(18×15×13mm)2025-01-20
06978137010091Dental Lithium Disilicate Glass CeramicHT-B1 RC(18×15×13mm)2025-01-20
06978137010107Dental Lithium Disilicate Glass CeramicHT-B2 RC(18×15×13mm)2025-01-20
06978137010114Dental Lithium Disilicate Glass CeramicHT-B3 RC(18×15×13mm)2025-01-20
06978137010121Dental Lithium Disilicate Glass CeramicHT-B4 RC(18×15×13mm)2025-01-20
06978137010138Dental Lithium Disilicate Glass CeramicHT-C1 RC(18×15×13mm) 2025-01-20
06978137010145Dental Lithium Disilicate Glass CeramicHT-C2 RC(18×15×13mm) 2025-01-20
06978137010152Dental Lithium Disilicate Glass CeramicHT-C3 RC(18×15×13mm) 2025-01-20
06978137010169Dental Lithium Disilicate Glass CeramicHT-C4 RC(18×15×13mm) 2025-01-20
06978137010176Dental Lithium Disilicate Glass CeramicHT-D2 RC(18×15×13mm) 2025-01-20
06978137010183Dental Lithium Disilicate Glass CeramicHT-D3 RC(18×15×13mm) 2025-01-20
06978137010190Dental Lithium Disilicate Glass CeramicHT-D4 RC(18×15×13mm) 2025-01-20
06978137010206Dental Lithium Disilicate Glass CeramicHT-BL1 RC(18×15×13mm) 2025-01-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
D800FMAA05030Colour Liquid A4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA06030Colour Liquid B1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA07030Colour Liquid B2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA08030Colour Liquid B3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA09030Colour Liquid B4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA10030Colour Liquid C1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA11030Colour Liquid C2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA12030Colour Liquid C3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28