FDA.reportPublic FDA data

DENSOL

Primary DI
G8791021850
Brand
DENSOL
Company
DENSOL INTERNATIONAL (PRIVATE) LIMITED
Model
102-185
Catalog number
102-185
Device description
Scaler H6/H7 DE HH 6mm
Published
2026-08-18
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
EMNScaler, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMNScaler, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G8791021850PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual dental scaler, reusableA hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. 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
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
G879107241S0DENSOL107-241S107-241S2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G879102177H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102184H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102185H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102186H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102187H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102191H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102196H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102197H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102211H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102212H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102213H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G8791024050DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102RM340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
04963931271214NAYDM CORPORATIONEMN2026-07-09
04963931271221NAYDM CORPORATIONEMN2026-07-09
04963931271238NAYDM CORPORATIONEMN2026-07-09
04963931271245NAYDM CORPORATIONEMN2026-07-09
04963931271252NAYDM CORPORATIONEMN2026-07-09
04963931271269NAYDM CORPORATIONEMN2026-07-09
04963931271276NAYDM CORPORATIONEMN2026-07-09
04963931271283NAYDM CORPORATIONEMN2026-07-09
04963931271290NAYDM CORPORATIONEMN2026-07-09
04963931271306NAYDM CORPORATIONEMN2026-07-09
G149TBSB5010TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5020TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5030TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5040TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5110TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5150TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5190TBS BASICSACME ENTERPRISE.EMN2026-05-20