FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813066027
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
5257254
Device description
AMALGAM CON BLACK SMTH DE 1/2
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
EKGCONDENSER, AMALGAM AND FOIL, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKGCondenser, Amalgam And Foil, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889813066027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813066027008898130660278898130660270889813066027

GMDN Terms#

Term, Definition table
TermDefinition
Dental amalgam condenser, reusableA hand-held manual dental instrument intended for packing amalgam or direct filling gold (Au). It may be smooth or serrated in design and flat or curved in shape. 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
G149TBSB4160TBS BASICSACME ENTERPRISE.EKG2026-05-20
G149TBSB4170TBS BASICSACME ENTERPRISE.EKG2026-05-20
G149TBSB4180TBS BASICSACME ENTERPRISE.EKG2026-05-20
G149TBSB4190TBS BASICSACME ENTERPRISE.EKG2026-05-20
00348783012323Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKG2026-04-30
10889950147242Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147259Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147266Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147273Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147280Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147297Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147303Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147310Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147327Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147334Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147341Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147358Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147365Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147686Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147785Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147839Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147853Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147860Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950147877Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950148447Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
10889950148454Hu-FriedyHU-FRIEDY MFG. CO., LLCEKG2026-02-24
07898506843541QuinelatoSchobell Industrial LtdaEKG2022-12-08
07898506843657QuinelatoSchobell Industrial LtdaEKG2022-12-08
07899798200029QuinelatoSchobell Industrial LtdaEKG2022-12-08
10889950019129HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKG2020-11-12