FDA.report

Dental City

Primary DI
D77162950CL0
Brand
Dental City
Company
ICP, INC.
Model
62-950CL
Device description
Saliva Ejector Clear W/ Blue Tip Latex Free 100/Bag TCS
Published
2021-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
D77162950CL1PrimaryHIBCC0
D77162950CL0Unit of UseHIBCC0

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
808371371
Device count
100
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D77114705LG0Stratus14-705LG2026-03-24
D77114705MD0Stratus14-705MD2026-03-24
D77114705SM0Stratus14-705SM2026-03-24
D77114705XL0Stratus14-705XL2026-03-24
D77114705XS0Stratus14-705XS2026-03-24
D7714227200BG0Dental City42-27200BG42-27200BG2026-03-24
D7714227200M0Dental City42-27200M42-27200M2026-03-24
D7714227200ML0Dental City42-27200ML2026-03-24
D771422750ML0Dental City42-2750ML2026-03-24
D77116100LG0Guardian16-100LG2026-03-19
D77116100MD0Guardian16-100MD2026-03-19
D77116100SM0Guardian16-100SM2026-03-19
D77116100XL0Guardian16-100XL2026-03-19
D77116100XS0Guardian16-100XS2026-03-19
D77114701LG0Dental City14-701LG2023-06-02
D77114701MD0Dental City14-701MD2023-06-02
D77114701SM0Dental City14-701SM2023-06-02
D77114701XL0Dental City14-701XL2023-06-02
D77114701XS0Dental City14-701XS2023-06-02
D77114715LG0Dental City14-715LG2023-06-02

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07615208584981Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
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D9099002011ORTHO ARCHOrtho Arch Company IncDYN2025-09-15
00840456209158JMUJMU DENTAL, INCDYN2025-06-17
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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
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