FDA.reportPublic FDA data

SPREADERS

Primary DI
07640142420293
Brand
SPREADERS
Company
FKG Dentaire Sàrl
Model
02.111.25.025.CG
Catalog number
02.111.25.025.CG
Device description
Spreaders 111, 25 mm, # 25, handle SMG
Published
2022-08-14
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
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
07640142420293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640142420293076401424202937640142420293

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
482884061
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640452461030EdgeGlidepathEGP0221HTS4EGP0221HTS42026-06-03
07640452461047EdgeGlidepathEGP0225HTSEGP0225HTS2026-06-03
07640452461054EdgeGlidepathEGP0231HTSEGP0231HTS2026-06-03
07640452461061EdgeOne FireEOF21ASSTEOF21ASST2026-06-03
07640452461078EdgeOne FireEOF25ASSTEOF25ASST2026-06-03
07640452461085EdgeOne FireEOF31ASSTEOF31ASST2026-06-03
07640452461092EdgeOne FireEOF21ASSTDEOF21ASSTD2026-06-03
07640452461108EdgeOne FireEOF25ASSTDEOF25ASSTD2026-06-03
07640452461115EdgeOne FireEOF31ASSTDEOF31ASSTD2026-06-03
07640452461122EdgeOne FireEOFLG21HTSEOFLG21HTS2026-06-03
07640452461139EdgeOne FireEOFLG25HTSEOFLG25HTS2026-06-03
07640452461146EdgeOne FireEOFLG31HTSEOFLG31HTS2026-06-03
07640452461153EdgeOne FireEOFMED21HTSEOFMED21HTS2026-06-03
07640452461160EdgeOne FireEOFMED25HTSEOFMED25HTS2026-06-03
07640452461177EdgeOne FireEOFMED31HTSEOFMED31HTS2026-06-03
07640452461184EdgeOne FireEOFPRI21HTSEOFPRI21HTS2026-06-03
07640452461191EdgeOne FireEOFPRI25HTSEOFPRI25HTS2026-06-03
07640452461207EdgeOne FireEOFPRI31HTSEOFPRI31HTS2026-06-03
07640452461214EdgeOne FireEOFSM21HTSEOFSM21HTS2026-06-03
07640452461221EdgeOne FireEOFSM25HTSEOFSM25HTS2026-06-03

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
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