FDA.report

SWIK

Primary DI
00860349001713
Brand
SWIK
Company
Saliva Management Systems, Inc.
Model
SWK-200
Device description
Non-Invasive oral secretion management tool.
Published
2024-05-05
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

Related Records

Product Codes

CodeName
DYNMouthpiece, Saliva Ejector

Product Code Classifications

CodeDeviceSpecialtyClass
DYNMouthpiece, Saliva EjectorDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10860349001703PackageGS110Not in Commercial Distribution
10860349001710PackageGS1100Not in Commercial Distribution
20860349001717PackageGS150Not in Commercial Distribution
30860349001714PackageGS125Not in Commercial Distribution
00860349001713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1086034900170310860349001703
1086034900171010860349001710
2086034900171720860349001717
3086034900171430860349001714
00860349001713008603490017138603490017130860349001713

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods

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 DIBrandModelCatalogPublished
00860349001720SWIK Modular MouthpieceSWK-M16SWK-M162025-06-17
00860349001737SWIK Modular Extension TubingSWK-T56SWK-T562025-06-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
07615208584981Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
07615208584998Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
07615208543506Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
D9099002011ORTHO ARCHOrtho Arch Company IncDYN2025-09-15
00840456209158JMUJMU DENTAL, INCDYN2025-06-17
00860349001720SWIK Modular MouthpieceSaliva Management Systems, Inc.DYN2025-06-17
00860349001737SWIK Modular Extension TubingSaliva Management Systems, Inc.DYN2025-06-17
00840161310668Pink Petal™ - Saliva Ejector Holder - 100 CountZIRC DENTAL PRODUCTS, INC.DYN2025-01-09
50732224005008Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22
50732224004988Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22
50732224005015Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22
50732224005022Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22
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TQ26SE2555120Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
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TQ26SE2555720Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555820Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555920Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2556020Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2556120Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
00304040186527Henry ScheinHENRY SCHEIN, INC.DYN2024-09-19
00304040186534Henry ScheinHENRY SCHEIN, INC.DYN2024-09-19