FDA.reportPublic FDA data

Anterior Mouthpiece

Primary DI
00810032660369
Brand
Anterior Mouthpiece
Company
ZYRIS, INC.
Model
CAM0301
Catalog number
CAM0301
Device description
Anterior Mouthpiece, 10-Pack, Large
Published
2024-04-08
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
00810032660369PrimaryGS10
10810032660366Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810032660369008100326603698100326603690810032660369
1081003266036610810032660366

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

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

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06954454000885COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
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06954454000915COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
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06954454000939COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000946COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000953COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000960COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002001COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
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06954454002315COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
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06954454002834COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
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06954454005026COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006085COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
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06954454006245COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006252COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006429COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454011867COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454013489COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454013496COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21