FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813065150
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
5257168
Device description
EXPLORER 6 SE
Published
2024-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00889813065150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813065150008898130651508898130651500889813065150

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
825137818
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889813067970Darby Dental Supply, LLC95377462026-03-22
00889813067987Darby Dental Supply, LLC95377502026-03-22
00889813067994Darby Dental Supply, LLC525879552587952026-02-12
00889813068007Darby Dental Supply, LLC525879652587962026-02-12
00889813068021Darby Dental Supply, LLC525879752587972026-02-12
00889813068038Darby Dental Supply, LLC525879852587982026-02-12
00889813068045Darby Dental Supply, LLC525879952587992026-02-12
00889813068052Darby Dental Supply, LLC525879052587902026-02-12
00889813068069Darby Dental Supply, LLC525879152587912026-02-12
00889813068076Darby Dental Supply, LLC525879252587922026-02-12
00889813068083Darby Dental Supply, LLC525879352587932026-02-12
00889813068090Darby Dental Supply, LLC525879452587942026-02-12
00889813048566Darby Dental Supply, LLC943020394302032022-07-18
00889813048580Darby Dental Supply, LLC943020494302042022-07-18
00889813048610Darby Dental Supply, LLC943020594302052022-07-18
00889813048672Darby Dental Supply, LLC943021094302102022-07-18
00889813048696Darby Dental Supply, LLC943021194302112022-07-18
00889813048719Darby Dental Supply, LLC943021294302122022-07-18
00889813048443Darby Dental Supply, LLC943020294302022022-07-18
00889813048511Darby Dental Supply, LLC943020194302012022-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10889950010799HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010805HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010812HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010829HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010836HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010843HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010850HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010867HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010874HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010881HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010898HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010904HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010911HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010928HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12