FDA.reportPublic FDA data

DENSOL

Primary DI
G879102132H0
Brand
DENSOL
Company
DENSOL INTERNATIONAL (PRIVATE) LIMITED
Model
102-132H
Catalog number
102-132H
Device description
Explorer DE #ODU11/12 Hollow Handle 10mm
Published
2026-08-08
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
EKBExplorer, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKBExplorer, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G879102132H0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical probe, reusableA slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. 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
G8791021190DENSOL102-119102-1192026-08-08
G8791021196L0DENSOL102-119-6L102-119-6L2026-08-08
G8791021200DENSOL102-120102-1202026-08-08
G8791021250DENSOL102-125102-1252026-08-08
G879102131H0DENSOL102-131H102-131H2026-08-08
G879102133H0DENSOL102-133H102-133H2026-08-08
G879102134H0DENSOL102-134H102-134H2026-08-08
G879102135H0DENSOL102-135H102-135H2026-08-08
G879102136H0DENSOL102-136H102-136H2026-08-08
G8791021510DENSOL102-151102-1512026-08-08
G8791021511B0DENSOL102-1511B102-1511B2026-08-08
G879102151H0DENSOL102-151H102-151H2026-08-08
G879102157H0DENSOL102-157H102-157H2026-08-08
G879102158H0DENSOL102-158H102-158H2026-08-08
G879102159H0DENSOL102-159H102-159H2026-08-08
G87910217U150DENSOL102-17U15102-17U152026-08-08
G87910217W0DENSOL102-17W102-17W2026-08-08
G87910218W0DENSOL102-18W102-18W2026-08-08
G87910219W0DENSOL102-19W102-19W2026-08-08
G8791021NH0DENSOL102-1NH102-1NH2026-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791021190DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G8791021196L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G8791021200DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G8791021250DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102131H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102133H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102134H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102135H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102136H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
00887919683902Brasseler USAPeter Brasseler Holdings, LLCEKB2026-07-13
08800017902470FriendoDXM CO., LTDEKB2026-07-13
08800017902487Gutta EasyDXM CO., LTDEKB2026-07-13
08800017902494Gutta EasyDXM CO., LTDEKB2026-07-13
00850083275686Intrace USAPILOTIS TECH LLCEKB2026-07-03
G149TBSB2010TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2020TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2030TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2040TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2050TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3010TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3020TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3030TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3040TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3050TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3060TBS BASICSACME ENTERPRISE.EKB2026-05-16
10889950002916HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010027HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010034HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010041HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010058HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12