FDA.reportPublic FDA data

Awesome Dental Products

Primary DI
00850059014721
Brand
Awesome Dental Products
Company
AWESOME DENTAL PRODUCTS, LLC
Model
HTI12BL1
Device description
Milling Blocks High Translucency I12 BL1
Published
2024-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
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
10850059014728PrimaryGS10
00850059014721Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085005901472810850059014728
00850059014721008500590147218500590147210850059014721

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119145297
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
10850059014001Awesome Dental ProductsLTC14A12024-06-17
10850059014018Awesome Dental ProductsLTC14A22024-06-17
10850059014025Awesome Dental ProductsLTC14A32024-06-17
10850059014032Awesome Dental ProductsLTC14A3.52024-06-17
10850059014049Awesome Dental ProductsLTC14A42024-06-17
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

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Primary DI, Brand, Company table
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