FDA.reportPublic FDA data

Foam Insert (Single Use) 144 pack

Primary DI
10840161302172
Brand
Foam Insert (Single Use) 144 pack
Company
ZIRC DENTAL PRODUCTS, INC.
Model
50Z466V
Device description
"Foam refills for Assist Stand Single use only/disposable"
Published
2022-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
10840161302172PrimaryGS10
00840161302175Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084016130217210840161302172
00840161302175008401613021758401613021750840161302175

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction system in-line filterA screening device designed to be fitted in the suction line of a dental suction system (e.g., in the saliva ejector valve) to trap debris [e.g., amalgam, bone particles, dentin/enamel particles] and stop them from entering the mains drainage system during a dental procedure. It is in the form of cylindrical/conical flange with numerous small openings. The device is not intended to be used as a dedicated autologous bone particle collector. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height15Millimeter
Length45Millimeter
Width23Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
064783913
Device count
144
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840161311511Crystal HD® Mouth Mirrors50Z364SMPL-US2026-02-19
00840161311535Crystal HD® Mouth Mirrors50Z384SMPL-US2026-02-19
00840161311559Midmark - Magnetic Bur Block - 14-Hole - Neon Blue - 1 Count50Z403N-MID2026-02-19
00840161302144Patterson Dental - Steri-Endo Guard, Endo Assist - Replacement Foam for Steri-En50Z451-PAT2026-02-19
00840161311689Insti-Dam® - Latex-Free Rubber Dam - Relaxed Fit - 1 Count Sample Pack50Z457SMPL-US2026-02-19
00840161311702Insti-Dam® - Latex-Free Rubber Dam - 1 Count Sample Pack50Z459SMPL-US2026-02-19
00840161311733Lingua-Fix® - Low-Volume Evacuator - 1 Count Sample Pack50Z953SMPL-US2026-02-19
00840161311740Airway Armor® - Throat Guard - 3 Count Sample Pack50Z960SMPL-US2026-02-19
00840161311764SE Cushion - Saliva Ejector Cushion - 5 Count Sample Pack50Z970SMPL-US2026-02-19
00840161311788Pink Petal™ - Saliva Ejector Holder - 3 Count Sample Pack50Z976SMPL-US50Z9762026-02-19
00840161311801Mr. Thirsty® One-Step - High Volume Evacuator - Variety 3 Count Sample P50Z989SMPL-US2026-02-19
00840161301468Steri-Endo Guard - Endo Holder - Hand - White - 1 Count50Z450A50Z450A2026-02-14
00840161301475Steri-Endo Guard - Endo Holder - Hand - Blue - 1 Count50Z450B50Z450B2026-02-14
00840161301482Steri-Endo Guard - Endo Holder - Hand - Green - 1 Count50Z450D50Z450D2026-02-14
00840161301499Steri-Endo Guard - Endo Holder - Hand - Beige - 1 Count50Z450G50Z450G2026-02-14
00840161301505Steri-Endo Guard - Endo Holder - Hand - Gray - 1 Count50Z450I50Z450I2026-02-14
00840161301512Steri-Endo Guard - Endo Holder - Hand - Plum - 1 Count50Z450E50Z450E2026-02-14
00840161301529Steri-Endo Guard - Endo Holder - Hand - Teal - 1 Count50Z450J50Z450J2026-02-14
00840161301536Steri-Endo Guard - Endo Holder - Hand - Red - 1 Count50Z450M50Z450M2026-02-14
00840161301543Steri-Endo Guard - Endo Holder - Hand - Midnight - 1 Count50Z450T50Z450T2026-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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
TQ26SE2555020Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555120Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
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TQ26SE2555320Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555420Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
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TQ26SE2555600Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
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