FDA.reportPublic FDA data

DENSOL

Primary DI
G8791027580
Brand
DENSOL
Company
DENSOL INTERNATIONAL (PRIVATE) LIMITED
Model
102-758
Catalog number
102-758
Device description
Dental Excavators 1.2mm Round Spoon Slim Handle
Published
2026-08-17
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
EKCExcavator, Dental, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKCExcavator, Dental, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G8791027580PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental excavator, reusableA hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. 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
G8791021110DENSOL102-111102-1112026-08-25
G8791023020DENSOL102-302102-3022026-08-25
G8791023030DENSOL102-303102-3032026-08-25
G879102305TIT0DENSOL102-305TIT102-305TIT2026-08-25
G8791023340DENSOL102-334102-3342026-08-25
G879102335TIT0DENSOL102-335TIT102-335TIT2026-08-25
G8791023580DENSOL102-358102-3582026-08-25
G8791023590DENSOL102-359102-3592026-08-25
G879102477TIT0DENSOL102-477TIT102-477TIT2026-08-25
G879LXB50DENSOLLXB5LXB52026-08-25
G8791002410DENSOL100-241100-2412026-08-23
G8791002510DENSOL100-251100-2512026-08-23
G879102124H0DENSOL102-124102-1242026-08-23
G8791021380DENSOL102-138102-1382026-08-23
G8791024320DENSOL102-432102-4322026-08-23
G8791024330DENSOL102-433102-4332026-08-23
G8791024340DENSOL102-434102-4342026-08-23
G8791024510DENSOL102-451102-4512026-08-22
G8791024520DENSOL102-452102-4522026-08-22
G879102453H0DENSOL102-453H102-453H2026-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791022620DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022630DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022640DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022950DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022960DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022970DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022980DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791027590DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791027600DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G87910217W0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G87910218W0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G87910219W0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022430DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022440DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022450DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022650DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022660DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022670DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX11L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX31L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX31W0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX32L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX33L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
00850083275624Intrace USAPILOTIS TECH LLCEKC2026-07-03
00348783008500Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008517Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008524Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008531Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008548Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008555Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08