FDA.reportPublic FDA data

Essentials by 3D Dental

Primary DI
00817169024279
Brand
Essentials by 3D Dental
Company
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Model
EJCB
Catalog number
EJCB
Device description
Saliva Ejector 100/Pk Clear W/Blue Case Pack 10/Cs
Published
2022-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DYNMouthpiece, Saliva Ejector

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYNMouthpiece, Saliva EjectorDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817169024276PackageGS110In Commercial Distribution
00817169024279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081716902427610817169024276
00817169024279008171690242798171690242790817169024279

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction system cannula, single-useA semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.

Sterilization Methods#

Method table
Method

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
00810194404023AiraAIRA, LLCDYN2026-08-26
00810194404122AiraAIRA, LLCDYN2026-08-26
00810194404146AiraAIRA, LLCDYN2026-08-26
00810194404160AiraAIRA, LLCDYN2026-08-26
00810194404184AiraAIRA, LLCDYN2026-08-26
00840456202678JMUJMU DENTAL, INCDYN2026-07-06
00840456214602JMUJMU DENTAL, INCDYN2026-07-06
00840456202654JMUJMU DENTAL, INCDYN2026-06-23
00840456202661JMUJMU DENTAL, INCDYN2026-06-23
00840456202685JMUJMU DENTAL, INCDYN2026-06-23
00840456216958JMUJMU DENTAL, INCDYN2026-06-23
00840456216965JMUJMU DENTAL, INCDYN2026-06-23
00840456216972JMUJMU DENTAL, INCDYN2026-06-23
D77162950AS1Dental CityICP, INC.DYN2026-05-27
00840161307118Mr. Thirsty® One-Step - High Volume Evacuator - Large - 1 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-30
00840161307132Mr. Thirsty® One-Step - High Volume Evacuator - MediumZIRC DENTAL PRODUCTS, INC.DYN2026-04-30
60840161307110Mr. Thirsty® One-Step - Large (with 10mm and 16mm Adaptors) - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
60840161307134Mr. Thirsty® One-Step - Medium (with 10mm and 16mm Adaptors) - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
60840161307158Mr. Thirsty® One-Step - Small (with 10mm and 16mm Adaptors) - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
70840161307117Mr. Thirsty® One-Step - Large (with 10mm and 16mm Adaptors) - 100 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
70840161307131Mr. Thirsty® One-Step - Medium (with 10mm and 16mm Adaptors) - 100 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
70840161307155Mr. Thirsty® One-Step - Small (with 10mm and 16mm Adaptors) - 100 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
00840161307125Mr. Thirsty® One-Step - High Volume Evacuator - Large - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
00840161307149Mr. Thirsty® One-Step - High Volume Evacuator - Medium - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
00840161304735Lingua-Fix® - Low-Volume Evacuator - 10 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-07
00840161304742Lingua-Fix® - Low-Volume Evacuator - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-07
00840161304766SE Cushion - Saliva Ejector Cushion - 100 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-07
07615208536706Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
07615208536744Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
07615208536874Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04