FDA.reportPublic FDA data

Denco

Primary DI
06975718055366
Brand
Denco
Company
Shenzhen Denco Medical Co., Ltd
Model
Gutta Percha Pluggers #40-#80
Published
2023-12-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKKSpreader, Pulp Canal Filling Material, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKKSpreader, Pulp Canal Filling Material, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975718055366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975718055366069757180553666975718055366

GMDN Terms#

Term, Definition table
TermDefinition
Manual endodontic filling material spreaderA hand-held, manually-operated dental instrument specifically designed to compress filling materials in a root canal, mainly in a lateral direction. The working part is tapered, circular in cross-section and has a pointed tip. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
543035008
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06942512502266AVALON BIOMEDZ-Micro Opener 10.04 (3 units)ZMO12025-11-25
06942512509166AVALON BIOMEDZ-Micro Shaper 20 .02 (3 units)ZMS12025-11-25
06942512509173AVALON BIOMEDZ-Micro Shaper 25 .02 (3 units)ZMS22025-11-25
06942512509180AVALON BIOMEDZ-Micro Shaper 30 .02 (3 units)ZMS32025-11-25
06942512509197AVALON BIOMEDZ-Micro Shaper ASSORTED (3 units)ZMSA2025-11-25
06942512509203AVALON BIOMEDZ-Micro Opener 15.04 (3 units)ZMO22025-11-25
06942512509210AVALON BIOMEDZ-Micro Opener 20.04 (3 units)ZMO32025-11-25
06942512509227AVALON BIOMEDZ-Micro Opener ASSORTED (3 units)ZMOA2025-11-25
06942512507841AVALON BIOMEDAtacadores manuales Z-Plugger de Zarc (35/70)2025-10-11
06942512507858AVALON BIOMEDAtacadores manuales Z-Plugger de Zarc (40/80)2025-10-11
06942512507865AVALON BIOMEDAtacadores manuales Z-Plugger de Zarc (50/100)2025-10-11
06942512507872AVALON BIOMEDAtacadores manuales Z-Plugger de Zarc (60/120)2025-10-11
06942512507889AVALON BIOMEDAtacadores manuales Z-Plugger de Zarc (Surtido)2025-10-11
06942512500637AVALON BIOMEDBlueShaper sterile files 19mm ZX (6 units)2025-07-21
06942512500644AVALON BIOMEDBlueShaper sterile files 21mm Z2 (6 units)2025-07-21
06942512500651AVALON BIOMEDBlueShaper sterile files 21mm Z5 (6 units)2025-07-21
06942512500668AVALON BIOMEDBlueShaper sterile files 21mm Z6 (6 units)2025-07-21
06942512500675AVALON BIOMEDBlueShaper sterile files 21mm Z7 (6 units)2025-07-21
06942512500682AVALON BIOMEDBlueShaper sterile files 21mm Z1-Z4 (4 units)2025-07-21
06942512500699AVALON BIOMEDBlueShaper sterile files 25mm Z7 (6 units)2025-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783009422Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009439Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009446Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009460Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009484Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009507Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009514Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009521Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009538Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-05-06
00348783009477Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-03-17
00348783009491Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-03-17
00840456213513JMUJMU DENTAL, INCEKK2025-08-18
00889813066867Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKK2025-03-12
00841013120435American Eagle Instruments, Inc.AMERICAN EAGLE INSTRUMENTS, INC.EKK2025-02-18
00841013120442American Eagle Instruments, Inc.AMERICAN EAGLE INSTRUMENTS, INC.EKK2025-02-18
00889813066843Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKK2024-11-30
00889813066850Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKK2024-11-30
00813677024480PDT, Inc.PDT, INC.EKK2024-06-27
00813677024985PDT, Inc.PDT, INC.EKK2024-06-27
08800075609809OSUNG MNDOSUNG MND Co., Ltd.EKK2024-03-04
08800075624048OSUNG MNDOSUNG MND Co., Ltd.EKK2024-03-04
06975718055359Denco Shenzhen Denco Medical Co., LtdEKK2023-12-27
06975718055373Denco Shenzhen Denco Medical Co., LtdEKK2023-12-27
06975718055380Denco Shenzhen Denco Medical Co., LtdEKK2023-12-27
D6919053814Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053816Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053818Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053820Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053826Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053830Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17