FDA.reportPublic FDA data

DENSOL

Primary DI
G8791023940
Brand
DENSOL
Company
DENSOL INTERNATIONAL (PRIVATE) LIMITED
Model
102-394
Catalog number
102-394
Device description
Dental Ball Burnisher Hopson 2/2.5mm Slim Handle
Published
2026-08-10
Public version status
Update
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
EIYInstrument, Filling, Plastic, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G8791023940PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental spatula, reusableA hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. 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
G879102GS10DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS20DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS30DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS60DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102H1H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102H2H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102H3H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G149TBSB4010TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4020TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4030TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4040TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4050TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4060TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4070TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4080TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4140TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4150TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4200TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4210TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4220TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB8130TBS BASICSACME ENTERPRISE.EIY2026-05-18
G149TBSB8010TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149TBSB8020TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149TBSB8030TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149TBSB8040TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149NPBPT0NPSACME ENTERPRISE.EIY2026-05-01
08800075626134OSUNG MNDOSUNG MND Co., Ltd.EIY2025-11-03
07649988072451OdneFill TipOdne AGEIY2024-02-01