FDA.reportPublic FDA data

OPTRAGATE

Primary DI
DVIV590851WW1
Brand
OPTRAGATE
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
590851WW
Catalog number
590851WW
Device description
OptraGate Small Refill / 80
Published
2021-04-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
DVIV590851WW1PrimaryHIBCC0
DVIV590851WW0Unit of UseHIBCC0

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.

Regulatory Flags#

DUNS number
448015938
Device count
80
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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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08800325901462Perfit OneMLVatech mcis Co., LtdEIF2026-07-20