FDA.reportPublic FDA data

HU-FRIEDY

Primary DI
10889950021368
Brand
HU-FRIEDY
Company
HU-FRIEDY MFG. CO., LLC
Model
RCS0A
Catalog number
RCS0A
Device description
#0 SE Anterior Spreader
Published
2020-08-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
10889950021368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995002136810889950021368

GMDN Terms#

Term, Definition table
TermDefinition
Manual endodontic 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

Contacts#

Phone, Email table
PhoneEmail
+1(800)483-7433info@hu-friedy.com

Regulatory Flags#

DUNS number
005085972
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800012410956Hu-FriedySSC-KIT2026-10-20
08800012411038Hu-FriedySSC-URD22026-10-20
08800012411182Hu-FriedySSC-LRD52026-10-20
08800012411199Hu-FriedySSC-LRD62026-10-20
08800012411205Hu-FriedySSC-LRD72026-10-20
08800012411212Hu-FriedySSC-ULE22026-10-20
08800012411229Hu-FriedySSC-ULE32026-10-20
08800012411236Hu-FriedySSC-ULE42026-10-20
08800012411243Hu-FriedySSC-ULE52026-10-20
08800012411250Hu-FriedySSC-ULE62026-10-20
08800012411267Hu-FriedySSC-ULE72026-10-20
08800012411397Hu-FriedySSC-LRE22026-10-20
08800012411403Hu-FriedySSC-LRE32026-10-20
08800012411410Hu-FriedySSC-LRE42026-10-20
08800012410970Hu-FriedySSC-ULD22024-10-14
08800012410987Hu-FriedySSC-ULD32024-10-14
08800012410994Hu-FriedySSC-ULD42024-10-14
08800012411014Hu-FriedySSC-ULD62024-10-14
08800012411021Hu-FriedySSC-ULD72024-10-14
08800012411045Hu-FriedySSC-URD32024-10-14

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
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
06975718055366Denco 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
D6919053832Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17