FDA.reportPublic FDA data

DENSOL

Primary DI
G8791024510
Brand
DENSOL
Company
DENSOL INTERNATIONAL (PRIVATE) LIMITED
Model
102-451
Catalog number
102-451
Device description
Half Hollenback Carver #3S DE HH 6mm
Published
2026-08-22
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
EKHCarver, Dental Amalgam, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKHCarver, Dental Amalgam, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G8791024510PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental restoration carver, amalgam, reusableA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. 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
G8791024520DENSOL102-452102-4522026-08-22
G879102453H0DENSOL102-453H102-453H2026-08-22
G8791024540DENSOL102-454102-4542026-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791024520DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKH2026-08-22
G879102453H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKH2026-08-22
G8791024540DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKH2026-08-22
G879102455H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKH2026-08-22
G8791024570DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKH2026-08-22
G149TBSB4090TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4100TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4110TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4120TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4130TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4280TBS BASICSACME ENTERPRISE.EKH2026-05-20
10889950005375HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005382HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005399HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005405HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005412HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005429HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005436HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005443HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005450HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005467HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005474HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005481HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005498HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005504HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005818HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005825HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950006907HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950006914HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950006921HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12