FDA.reportPublic FDA data

BENCO

Primary DI
00366975049490
Brand
BENCO
Company
BENCO DENTAL SUPPLY CO.
Model
1189-822
Published
2022-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
00366975049490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00366975049490003669750494903669750494900366975049490

GMDN Terms#

Term, Definition table
TermDefinition
Mouth gag, non-adjustableA mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention. It is designed to be inserted between the teeth to force the jaws apart and may be in the form of a wedge block, wedge screw, or sprung wedge. Depending on the design it may also be referred to as a jaw spreader, oral wood screw, or mouth prop. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
015108087
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
00366975069993Sterling6694-6422025-02-26
00366975070005Sterling5259-5162025-02-26
00366975069344STERLING5259-507 2024-01-26
00366975013040STERLING5259-5072023-12-13
00366975012814STERLING4983-5662023-06-13
00366975066848OPTIMUM6032-0532023-02-21
00366975066855OPTIMUM6032-0712023-02-21
00366975066862OPTIMUM6032-0802023-02-21
00366975066879OPTIMUM6032-0992023-02-21
00366975066886OPTIMUM6032-1062023-02-21
00366975066893OPTIMUM6032-1152023-02-21
00366975066909OPTIMUM6032-1242023-02-21
00366975066916OPTIMUM6032-1332023-02-21
00366975066923OPTIMUM6032-1422023-02-21
00366975066930OPTIMUM6032-1512023-02-21
00366975066947OPTIMUM6032-1602023-02-21
00366975066954OPTIMUM6032-1792023-02-21
00366975066961OPTIMUM6032-1972023-02-21
00366975066978OPTIMUM6032-2042023-02-21
00366975066992OPTIMUM6032-2312023-02-21

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
TQ26SE2555220Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555320Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555420Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
TQ26SE2555520Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.DYN2024-10-31
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