FDA.reportPublic FDA data

Zyris

Primary DI
10810032660359
Brand
Zyris
Company
ZYRIS, INC.
Model
CAM0201
Catalog number
CAM0201
Device description
Anterior Mouthpiece, 10-Pack, Medium
Published
2024-04-08
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

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
00810032660352PrimaryGS10
10810032660359Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810032660352008100326603528100326603520810032660352
1081003266035910810032660359

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction protective mouthpieceA prefabricated device designed to be placed in the oral cavity during a dental procedure to protect the oral pathway by serving as a conduit for the continuous suction of debris/saliva, shielding the oral anatomy, maintaining an open mouth and retracted cheeks, and depressing the tongue. It is made of preformed materials for direct insertion into the mouth and includes features for connection to a dental suction unit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)560-6066regulatory@zyris.com

Regulatory Flags#

DUNS number
068038277
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810032660765Isolite, i3PIL0301PIL03012024-04-19
00810032660772Isolite, i3PIL0302PIL03022024-04-19
00810032660789Isolite, i3PIL0304PIL03042024-04-19
00810032660796Isolite, i3PIL0305PIL03052024-04-19
00810032660802Isolite, i3PIL0306PIL03062024-04-19
00810032660819Isolite, i3PIL0307PIL03072024-04-19
00810032660826Isolite, i3PIL0308PIL03082024-04-19
00810032660833Isolite, i3PIL0309PIL03092024-04-19
00810032660840Isolite, i3PIL0311PIL03112024-04-19
00810032660857Isolite, i3PIL0312PIL03122024-04-19
00810032660864Isolite, i3PIL0313PIL03132024-04-19
00810032660871Isolite, i3PIL0314PIL03142024-04-19
00810032660888Isolite, i3PIL0315PIL03152024-04-19
00810032660901Isolite, i3PIL0318PIL03182024-04-19
00810032660925Isolite, i3PIL0320PIL03202024-04-19
00810032660932Isolite, i3PIL0321PIL03212024-04-19
00810032660956Isolite, i3PIL0323PIL03232024-04-19
00810032660963Isolite, i3PIL0324PIL03242024-04-19
00810032660444Isolite, i3EIL0308EIL03082024-04-08
00810032660918Isolite, i3PIL0319PIL03192024-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194404023AiraAIRA, LLCDYN2026-08-26
00810194404122AiraAIRA, LLCDYN2026-08-26
00810194404146AiraAIRA, LLCDYN2026-08-26
00810194404160AiraAIRA, LLCDYN2026-08-26
00810194404184AiraAIRA, LLCDYN2026-08-26
00840456202678JMUJMU DENTAL, INCDYN2026-07-06
00840456214602JMUJMU DENTAL, INCDYN2026-07-06
00840456202654JMUJMU DENTAL, INCDYN2026-06-23
00840456202661JMUJMU DENTAL, INCDYN2026-06-23
00840456202685JMUJMU DENTAL, INCDYN2026-06-23
00840456216958JMUJMU DENTAL, INCDYN2026-06-23
00840456216965JMUJMU DENTAL, INCDYN2026-06-23
00840456216972JMUJMU DENTAL, INCDYN2026-06-23
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
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
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