FDA.reportPublic FDA data

SWIK Modular Mouthpiece

Primary DI
00860349001720
Brand
SWIK Modular Mouthpiece
Company
Saliva Management Systems, Inc.
Model
SWK-M16
Catalog number
SWK-M16
Device description
Non-Invasive oral secretion management tool. Modular design to be used with SWK-T56 Extension Tubing.
Published
2025-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DYNMouthpiece, Saliva Ejector
EHZEvacuator, Oral Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYNMouthpiece, Saliva EjectorDental1
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860349001720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860349001720008603490017208603490017200860349001720

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119148960
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860349001737SWIK Modular Extension TubingSWK-T56SWK-T562025-06-17
00860349001713SWIKSWK-2002024-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126505675Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEHZ2026-03-05
00840161311733Lingua-Fix® - Low-Volume Evacuator - 1 Count Sample PackZIRC DENTAL PRODUCTS, INC.DYN2026-02-19
00840161311764SE Cushion - Saliva Ejector Cushion - 5 Count Sample PackZIRC DENTAL PRODUCTS, INC.DYN2026-02-19
00840161311788Pink Petal™ - Saliva Ejector Holder - 3 Count Sample PackZIRC DENTAL PRODUCTS, INC.DYN2026-02-19
00840161311801Mr. Thirsty® One-Step - High Volume Evacuator - Variety 3 Count Sample PZIRC DENTAL PRODUCTS, INC.DYN2026-02-19
00849296017800WelmedWELMED INC.EHZ2026-02-15
00849296017817WelmedWELMED INC.EHZ2026-02-15
00723896029855Practicon Color Splash™ Saliva Ejectors 100/PackPRACTICON, INC.EHZ2026-01-08
07615208584981Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
07615208584998Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
07615208543506Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
00841336128811Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-20
00371347017793Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
00371347017809Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
00371347017816Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
00371347017823Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
00841336105553Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336105560Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336105577Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336108509Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336108578Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336109995Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336110489Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336111639Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
D9099002011ORTHO ARCHOrtho Arch Company IncDYN2025-09-15
00842517104747Karl SchumacherKarl Schumacher Dental, LLCEHZ2025-07-08
00840456209158JMUJMU DENTAL, INCDYN2025-06-17
00860349001737SWIK Modular Extension TubingSaliva Management Systems, Inc.EHZ2025-06-17
00860349001737SWIK Modular Extension TubingSaliva Management Systems, Inc.DYN2025-06-17
00842517104129Karl SchumacherKarl Schumacher Dental, LLCEHZ2025-04-23