FDA.reportPublic FDA data

Essentials by 3D Dental

Primary DI
00817169029601
Brand
Essentials by 3D Dental
Company
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Model
ESA-L
Catalog number
ESA-L
Device description
Essentials Cotton roll substitute Super absorber Large Box/50
Published
2023-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KHRAbsorber, Saliva, Paper

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHRAbsorber, Saliva, PaperDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817169029601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817169029601008171690296018171690296010817169029601

GMDN Terms#

Term, Definition table
TermDefinition
Saliva absorbentA non-sterile device designed to absorb moisture from the oral cavity during a dental procedure. Also known as a saliva absorber, it can be in a variety of shapes and sizes and is typically made of paper, cotton, or polymeric web, and may have a high-absorbent core. This is a single-use device.

Regulatory Flags#

DUNS number
080194935
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810126508362Essentials By 3D DentalGN300-L2026-04-16
008101265062213D DentalRCPC2026-03-24
00810126506757Comfortox5CC30132026-03-24
00810126506764Comfortox5CC2982026-03-24
00810126508355Basik by 3D DentalBPGLA4672026-03-17
00810126508331Basik by 3D DentalBPGC9422026-03-17
00810126508348Basik by 3D DentalBPGC9432026-03-17
10817169023019Basik by 3D DentalBPGLA4672026-03-17
008171690214833D Dental - DreamDFVMLDFVML2023-01-11
00817169023005Basik by 3D DentalBPGLA4532026-03-17
00810126506054The Essentials By 3D DentalPL-HCSPL-HCS2023-02-28
00810126506061The Essentials By 3D DentalPL-HRLGPL-HRLG2023-02-28
008171690201723D Dental - DreamDFVBG2016-12-12
008171690201893D Dental - DreamDFVSM2016-12-12
008171690214763D Dental-DreamDFVCM2017-12-04
008171690219643D Dental- BiovivaBHG2018-08-30
008101265081643D DentalJSM-CN2026-03-16
008101265081713D DentalJSM-CW2026-03-16
008101265081883D DentalJSM-N2026-03-16
008101265081953D DentalJSM-W2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456217696JMUJMU DENTAL, INCKHR2026-06-05
00840456222188JMUJMU DENTAL, INCKHR2026-06-05
00840456222195JMUJMU DENTAL, INCKHR2026-06-05
00840456223000JMUJMU DENTAL, INCKHR2026-06-05
00840456223017JMUJMU DENTAL, INCKHR2026-06-05
00840456201756JMUJMU DENTAL, INCKHR2026-05-27
00840456201763JMUJMU DENTAL, INCKHR2026-05-27
00840456201770JMUJMU DENTAL, INCKHR2026-05-27
00840456201787JMUJMU DENTAL, INCKHR2026-05-27
00840456201794JMUJMU DENTAL, INCKHR2026-05-27
00840456221020JMUJMU DENTAL, INCKHR2026-05-27
10371347011439Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011446Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011453Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011460Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011477Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011484Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011491Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011507Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
50732224004650Econoback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004704Sani-Tab Chain-Free Polyback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004711Sani-Tab Chain-Free Polyback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004728Sani-Tab Chain-Free Polyback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004735Sani-Tab Chain-Free Econoback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004742Sani-Tab Chain-Free Econoback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004759Sani-Tab Chain-Free Econoback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004766Sani-Tab Chain-Free Econoback TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004773Professional Regular TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004780Professional Regular TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17
50732224004797Professional Regular TowelsCROSSTEX INTERNATIONAL, INC.KHR2023-07-17