FDA.reportPublic FDA data

Oral retractor

Primary DI
06970873260334
Brand
Oral retractor
Company
DENJOY DENTAL CO.,LTD
Model
DY20-1,DY20-2
Published
2022-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06970873260334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970873260334069708732603346970873260334

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529329650
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06979865810137JAS Heat Plugger TipsJAS HPT2026-09-24
06979865810175JAS Unit Endo SystemJAS Unit2026-09-24
06979865810038JAS MotorJAS M2026-09-24
06979865810045JAS FillJAS F2026-09-24
06979865810052JAS PexJAS P2026-09-24
06979865810069JAS ActivatorJAS A2026-09-24
06979865810076JAS Charging UnitJAS CU2026-09-24
06979865810083JAS Contra-AngleJAS CA2026-09-24
06979865810090JAS Power SupplyJAS PS2026-09-24
06979865810106JAS Activator Ultrasonic TipsJAS UT2026-09-24
06979865810113JAS Fill Gutta-Percha NeedlesJAS GPN2026-09-24
06979865810120JAS Gutta-Percha PelletsJAS GPP2026-09-24
06979865810151JAS Unit Endo System plus JAS Pack Gutta-Percha CutterJAS Kit2026-09-24
06979865810168JAS Pack Gutta-Percha CutterJAS Pack2026-09-24
06979865810007Integrated Endo SystemMeet Endo-II2026-03-31
06979865810014Gutta Percha CutterMeta Pack2026-03-31
06970873260389Integrated Endo System Meet Endo-II2025-02-28
06970873260297Root Canal Instruments KitDY21-12022-02-19
06970873260013PULP TESTERDY3102022-02-19
06970873260051Endo Motor RCTI-DY(II)2022-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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