FDA.reportPublic FDA data

DENSOL

Primary DI
G8791062340
Brand
DENSOL
Company
DENSOL INTERNATIONAL (PRIVATE) LIMITED
Model
106-234
Catalog number
106-234
Device description
Mouth Gag Molt 9cm
Published
2026-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KBNGag, Mouth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBNGag, MouthEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G8791062340PrimaryHIBCC0

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
775322952
Device count
1
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G879101067S0DENSOL101-067S101-067S2026-08-13
G879102177H0DENSOL102-177H102-177H2026-08-18
G879102184H0DENSOL102-184H102-184H2026-08-18
G8791021850DENSOL102-185102-1852026-08-18
G879102185H0DENSOL102-185H102-185H2026-08-18
G879102186H0DENSOL102-186H102-186H2026-08-18
G879102187H0DENSOL102-187H102-187H2026-08-18
G879102191H0DENSOL102-191H102-191H2026-08-18
G879102196H0DENSOL102-196H102-196H2026-08-18
G879102197H0DENSOL102-197H102-197H2026-08-18
G879102211H0DENSOL102-211H102-211H2026-08-18
G879102212H0DENSOL102-212H102-212H2026-08-18
G879102213H0DENSOL102-213H102-213H2026-08-18
G8791024050DENSOL102-405102-4052026-08-18
G879102RM340DENSOL102-RM34102-RM342026-08-18
G8791062750DENSOL106-275106-2752026-08-18
G879107193L0DENSOL107-193L107-193L2026-08-18
G879107193S0DENSOL107-193S107-193S2026-08-18
G879107241L0DENSOL107-241L107-241L2026-08-18
G879107241M0DENSOL107-241M107-241M2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791062360DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDKBN2026-08-15
G8791062380DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDKBN2026-08-15
00190776405755MillenniumAvalign Technologies, Inc.KBN2026-07-24
14026704810069PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810076PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810083PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810090PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810106PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810113PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
14026704810120PILLINGTELEFLEX INCORPORATEDKBN2022-12-08
ESAM4011541STOMA®Storz am Mark GmbHKBN2022-11-07
ESAM3725121STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM3740111STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM3740141STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033001STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033011STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033021STOMA®Storz am Mark GmbHKBN2020-08-27
ESAM4033031STOMA®Storz am Mark GmbHKBN2020-08-27
10889950015695Hu-FriedyHU-FRIEDY MFG. CO., LLCKBN2020-08-14
10889950015701Hu-FriedyHU-FRIEDY MFG. CO., LLCKBN2020-08-14
10889950015718Hu-FriedyHU-FRIEDY MFG. CO., LLCKBN2020-08-14
10381780448822Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-10-23
14026704630742PILLINGTELEFLEX INCORPORATEDKBN2018-10-22
10381780506485Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-09-12
10381780507857Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-09-12
10381780487807Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-29
10381780487814Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-20
10381780487821Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-20
10381780487845Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-20
10381780437963Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKBN2018-08-16