FDA.reportPublic FDA data

OptraGate 2

Primary DI
07615208535907
Brand
OptraGate 2
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
757915WW
Catalog number
757915WW
Device description
OptraGate 2 Assortment
Published
2025-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EIFACCESSORIES, RETRACTOR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07615208516982PrimaryGS10
07615208535907Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07615208516982076152085169827615208516982
07615208535907076152085359077615208535907

GMDN Terms#

Term, Definition table
TermDefinition
Dental cheek retractor, professional, single-useA hands-free, self-retaining frame intended to allow a dental professional to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure for easy access to the field of operation. It is designed to be placed in and around the lips/cheeks and may also be designed to displace the tongue. It is a synthetic polymer device which may include suction adaptors/tubing for saliva removal to maintain a dry field. It is not intended to be placed between the teeth (i.e., not a mouth gag). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
448015938
Device count
80
DM exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07615208353723Mixing Tips6459556459552026-08-19
DVIV533297AN1Helioseal533297AN533297AN2016-11-18
DVIV550578AN1Fluor Protector550578AN550578AN2016-12-12
DVIV550579AN1Fluor Protector550579AN550579AN2016-12-12
07615208476804Tetric plus Fill762371WW762371WW2026-07-29
07615208476811Tetric plus Fill762372WW762372WW2026-07-29
07615208476828Tetric plus Fill762373WW762373WW2026-07-29
07615208476835Tetric plus Fill762374WW762374WW2026-07-29
07615208476842Tetric plus Fill762375WW762375WW2026-07-29
07615208477658Tetric plus Fill762386WW762386WW2026-07-29
07615208477665Tetric plus Fill762387WW762387WW2026-07-29
07615208477672Tetric plus Fill762388WW762388WW2026-07-29
07615208477689Tetric plus Fill762389WW762389WW2026-07-29
07615208477696Tetric plus Fill762390WW762390WW2026-07-29
07615208477702Tetric plus Flow762391WW762391WW2026-07-29
07615208477719Tetric plus Flow762392WW762392WW2026-07-29
07615208477726Tetric plus Flow762393WW762393WW2026-07-29
07615208477733Tetric plus Flow762394WW762394WW2026-07-29
07615208477740Tetric plus Flow762395WW762395WW2026-07-29
07615208477757Tetric plus Flow762396WW762396WW2026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D955RETWIED01Paul BandittTerlain Enterprises, Inc.EIF2026-09-25
00810194403415AiraAIRA, LLCEIF2026-08-26
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08800325901226Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
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08800325901318Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901325Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
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08800325901400Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
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08800325901424Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901431Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901448Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901455Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901462Perfit OneMLVatech mcis Co., LtdEIF2026-07-20