FDA.reportPublic FDA data

Awesome Dental Products

Primary DI
10850059014049
Brand
Awesome Dental Products
Company
AWESOME DENTAL PRODUCTS, LLC
Model
LTC14A4
Device description
Milling Blocks Low Translucency C14 A4
Published
2024-06-17
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
K222513000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222513000Glass CeramicsYilink (Tianjin) Biotechnology Co., Ltd.2023-02-10EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850059014049PrimaryGS10
00850059014042Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085005901404910850059014049
00850059014042008500590140428500590140420850059014042

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
119145297
Device count
5
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
10850059014001Awesome Dental ProductsLTC14A12024-06-17
10850059014018Awesome Dental ProductsLTC14A22024-06-17
10850059014025Awesome Dental ProductsLTC14A32024-06-17
10850059014032Awesome Dental ProductsLTC14A3.52024-06-17
10850059014056Awesome Dental ProductsLTC14B12024-06-17
10850059014063Awesome Dental ProductsLTC14B22024-06-17
10850059014070Awesome Dental ProductsLTC14C12024-06-17
10850059014087Awesome Dental ProductsLTC14C22024-06-17
10850059014094Awesome Dental ProductsLTC14D22024-06-17
10850059014100Awesome Dental ProductsLTC14D32024-06-17
10850059014117Awesome Dental ProductsLTC14BL12024-06-17
10850059014124Awesome Dental ProductsLTC14BL22024-06-17
10850059014131Awesome Dental ProductsLTC14BL32024-06-17
10850059014148Awesome Dental ProductsLTC14BL42024-06-17
10850059014155Awesome Dental ProductsHTC14A12024-06-17
10850059014162Awesome Dental ProductsHTC14A22024-06-17
10850059014179Awesome Dental ProductsHTC14A32024-06-17
10850059014186Awesome Dental ProductsHTC14A3.52024-06-17
10850059014193Awesome Dental ProductsHTC14A42024-06-17
10850059014209Awesome Dental ProductsHTC14B12024-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06976581410009Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410016Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410023Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410030Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410047Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410054Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410061Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410078Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
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