FDA.reportPublic FDA data

Isolite Moutpiece

Primary DI
00810032660239
Brand
Isolite Moutpiece
Company
ZYRIS, INC.
Model
CIL1101
Catalog number
CIL1101
Device description
Mouthpiece, 10-Pack, Extra Small
Published
2019-09-24
Public version status
Update
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
00810032660239PrimaryGS10
10810032660236Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810032660239008100326602398100326602390810032660239
1081003266023610810032660236

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held dental retractorA hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. This is a reusable device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
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
07615208536706Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
07615208536744Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
07615208536874Optragate Dry ControlIVOCLAR VIVADENT AKTIENGESELLSCHAFTDYN2025-12-04
07630716603658Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603665Geistlich PanoramaDSSM AGEIF2025-09-17