FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040186524
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5703902
Catalog number
5703902
Device description
ACCLEAN Hands-free HVE Standard Refill (100 pieces)
Published
2024-09-19
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
DYNMouthpiece, saliva ejector

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYNMouthpiece, Saliva EjectorDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040186524PrimaryGS10
00304040186527Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404018652410304040186524
00304040186527003040401865273040401865270304040186527

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction protective mouthpieceA prefabricated device designed to be placed in the oral cavity during a dental procedure to protect the oral pathway by serving as a conduit for the continuous suction of debris/saliva, shielding the oral anatomy, maintaining an open mouth and retracted cheeks, and depressing the tongue. It is made of preformed materials for direct insertion into the mouth and includes features for connection to a dental suction unit. This is a single-use device.

Regulatory Flags#

DUNS number
012430880
Device count
100
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040200589Henry Schein570609457060942026-10-06
10304040193843Henry Schein570560657056062026-10-05
10304040193850Henry Schein570560757056072026-10-05
10304040193867Henry Schein570560857056082026-10-05
10304040193874Henry Schein570560957056092026-10-05
10304040193881Henry Schein570561057056102026-10-05
10304040193898Henry Schein570561157056112026-10-05
10304040194109Henry Schein570562257056222026-10-05
10304040194116Henry Schein570562357056232026-10-05
10304040194208Henry Schein570569757056972026-10-05
10304040194215Henry Schein570569857056982026-10-05
10304040194222Henry Schein570569957056992026-10-05
10304040194239Henry Schein570570057057002026-10-05
10304040194246Henry Schein570570157057012026-10-05
10304040194253Henry Schein570570257057022026-10-05
10304040194260Henry Schein570570357057032026-10-05
10304040194277Henry Schein570570457057042026-10-05
10304040194284Henry Schein570570557057052026-10-05
10304040194291Henry Schein570570657057062026-10-05
10304040194307Henry Schein570570757057072026-10-05

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
00840161307156Mr. Thirsty® One-Step - High Volume Evacuator - Small - 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