FDA.reportPublic FDA data

Hygoformic™ Saliva Ejectors

Primary DI
00732224000824
Brand
Hygoformic™ Saliva Ejectors
Company
CROSSTEX INTERNATIONAL, INC.
Model
ZFFAD
Device description
Hygoformic Saliva Ejectors Adapters
Published
2022-09-29
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

Contact Domains#

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
10732224000821PrimaryGS10
00732224000824Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1073222400082110732224000821
00732224000824007322240008247322240008240732224000824

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(585)359-0167regulatoryaffairs@hu-friedy.com

Regulatory Flags#

DUNS number
057728685
Device count
10
DM exempt
true
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
true
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
30732224001136Self-Sealing Sterilization BagOCS2022-05-03
50732224005206Premium Non-Woven SpongesENCNW4KENCNW4K2025-10-23
50732224001086Ultra Gauze Non-Woven SpongesENCNWUBENCNWUB2025-10-23
10732224001088Ultra Gauze Non-Woven SpongesENCNWUBENCNWUB2022-08-25
10732224005208Premium Non-Woven SpongesENCNW4KENCNW4K2023-07-17
50732224000140Sani Vac Evacuation System CleanerJVACSAMPLESJVACSAMPLES2022-08-19
10732224110568Duo-Check Self-Sealing Sterilization PouchesSCM2025-07-24
10732224000050Crosstex InternationalSCMSCM2016-11-11
10732224109241Duo-Check Self-Sealing Sterilization PouchesSCB1XSCB1X2016-11-11
10732224109272Duo-Check Self-Sealing Sterilization PouchesSCLSCL2016-11-11
10732224109289Duo-Check Self-Sealing Sterilization PouchesSCL1015SCL10152016-11-11
10732224109296Sure-Check Self Sealing Sterilization PouchesSCL10152SCL101522016-11-11
10732224109319Sure-Check Self Sealing Sterilization PouchesSCL10172SCL101722017-02-11
10732224109326Duo-Check Self-Sealing Sterilization PouchesSCL1215SCL12152016-11-11
10732224109333Sure-Check Self Sealing Sterilization PouchesSCL12152SCL121522016-11-11
10732224109357Duo-Check Self-Sealing Sterilization PouchesSCL1218SCL12182016-11-11
10732224109364Sure-Check Self Sealing Sterilization PouchesSCL12182SCL121822016-11-11
10732224109388Sure-Check Self Sealing Sterilization PouchesSCL2SCL22016-11-11
10732224109395Duo-Check Self-Sealing Sterilization PouchesSCL322SCL3222017-02-11
10732224109401Sure-Check Self Sealing Sterilization PouchesSCL3222SCL32222017-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D77162950AS1Dental CityICP, INC.DYN2026-05-27
00840161307118Mr. Thirsty® One-Step - High Volume Evacuator - Large - 1 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-30
00840161307132Mr. Thirsty® One-Step - High Volume Evacuator - MediumZIRC DENTAL PRODUCTS, INC.DYN2026-04-30
00840161311887Mr. Thirsty® One-Step - High Volume Evacuator - SmallZIRC DENTAL PRODUCTS, INC.DYN2026-04-30
00840456218662JMUJMU DENTAL, INCDYN2026-04-14
00840456218679JMUJMU DENTAL, INCDYN2026-04-14
00840456220290JMUJMU DENTAL, INCDYN2026-04-14
60840161307110Mr. Thirsty® One-Step - Large (with 10mm and 16mm Adaptors) - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
60840161307134Mr. Thirsty® One-Step - Medium (with 10mm and 16mm Adaptors) - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
60840161307158Mr. Thirsty® One-Step - Small (with 10mm and 16mm Adaptors) - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
70840161307117Mr. Thirsty® One-Step - Large (with 10mm and 16mm Adaptors) - 100 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
70840161307131Mr. Thirsty® One-Step - Medium (with 10mm and 16mm Adaptors) - 100 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
70840161307155Mr. Thirsty® One-Step - Small (with 10mm and 16mm Adaptors) - 100 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
00840161307125Mr. Thirsty® One-Step - High Volume Evacuator - Large - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
00840161307149Mr. Thirsty® One-Step - High Volume Evacuator - Medium - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
00840161307156Mr. Thirsty® One-Step - High Volume Evacuator - Small - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
00840161308443Mr. Thirsty® One-Step - High Volume Evacuator - Small - 100 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
00840161309099Mr. Thirsty® One-Step - Variety Pack (with 10mm and 16mm Adaptors) - 30 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
00840161310484Mr. Thirsty® One-Step - Adaptor for Mr. Thirsty® One-Step - 10mm - 1 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
00840161310491Mr. Thirsty® One-Step - Adaptor for Mr. Thirsty® One-Step - 16mm - 1 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-08
00840161304735Lingua-Fix® - Low-Volume Evacuator - 10 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-07
00840161304742Lingua-Fix® - Low-Volume Evacuator - 50 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-07
00840161304766SE Cushion - Saliva Ejector Cushion - 100 CountZIRC DENTAL PRODUCTS, INC.DYN2026-04-07
07615208536706Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
07615208536744Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
07615208536874Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
10732224004980Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22
10732224005000Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22
10732224005017Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22
10732224005024Safe-Flo Plus Saliva EjectorCROSSTEX INTERNATIONAL, INC.DYN2024-11-22