FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813065433
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
5257196
Device description
EXCAVATOR LONG SHANK 32L DE
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
EKCEXCAVATOR, DENTAL, OPERATIVE

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889813065433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813065433008898130654338898130654330889813065433

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
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
07898506841585QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843282QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843299QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843305QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843763QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843770QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843787QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506851799QuinelatoSchobell Industrial LtdaEKC2022-12-08
10889950010065HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010072HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010089HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010096HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010102HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010119HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010126HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010133HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010140HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010157HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010164HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010171HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010188HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010195HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010201HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010218HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010225HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010232HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010249HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010256HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010263HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010270HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12