FDA.reportPublic FDA data

Isolite Mouthpiece

Primary DI
00810032661250
Brand
Isolite Mouthpiece
Company
ZYRIS, INC.
Model
AIL0250
Catalog number
AIL0250
Device description
Customer Success Kit, OUS
Published
2024-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYNMouthpiece, saliva ejector
EIFACCESSORIES, RETRACTOR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYNMouthpiece, Saliva EjectorDental1
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810032661250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810032661250008100326612508100326612500810032661250

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
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
00840456202678JMUJMU DENTAL, INCDYN2026-07-06
00840456214602JMUJMU DENTAL, INCDYN2026-07-06
00810230800666DCI PartsDCI International, LLCEIF2026-06-26
00810230800673DCI PartsDCI International, LLCEIF2026-06-26
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
D2486054630Spandex Advanced Junior/Small (Black)HAGER WORLDWIDE, INC.EIF2026-06-07
D2486054640Spandex Advanced Standard/Med (Pink)HAGER WORLDWIDE, INC.EIF2026-06-07
D2486054651Spandex Advanced - 3 Size Combo Kit- Black (1 Junior/Sm, 1 Standard/Med, 1 LargeHAGER WORLDWIDE, INC.EIF2026-06-07
D2486054661Spandex Advanced - 3 Size Combo Kit- Pink (1 Junior/Sm, 1 Standard/Med, 1 Large)HAGER WORLDWIDE, INC.EIF2026-06-07
00840456223093JMUJMU DENTAL, INCEIF2026-06-05
00840456223109JMUJMU DENTAL, INCEIF2026-06-05
00840456223116JMUJMU DENTAL, INCEIF2026-06-05
00840456223123JMUJMU DENTAL, INCEIF2026-06-05
D77162950AS1Dental CityICP, INC.DYN2026-05-27
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
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07615208536874Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
07630716603658Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603665Geistlich PanoramaDSSM AGEIF2025-09-17