FDA.reportPublic FDA data

PLUGGERS

Primary DI
07640142420187
Brand
PLUGGERS
Company
FKG Dentaire Sàrl
Model
02.110.25.020.CG
Catalog number
02.110.25.020.CG
Device description
Pluggers 110, 25 mm, # 20, 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
EKRPlugger, Root Canal, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKRPlugger, Root Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640142420187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640142420187076401424201877640142420187

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic pluggerA hand-held, manually-operated, dental instrument specifically designed to compress filling materials in a root canal, mainly in an axial direction. The working distal end is cylindrical or tapered, circular in cross-section, and has a flat-tipped end. 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
08404535018981Brasseler USAPeter Brasseler Holdings, LLCEKR2026-06-26
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00348783009019Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009026Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009033Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009057Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783008975Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008982Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008999Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009125Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009132Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009149Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008913Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008920Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008937Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008944Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008951Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009088Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009095Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009101Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783009118Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
E89616970207E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-10-14
E89616970307E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-10-14
E89616970TI07E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-10-14
E896169701TI07E0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-07-16
E8961697020TI0SCHWERTA. Schweickhardt GmbH & Co. KGEKR2025-06-24
00813677024480PDT, Inc.PDT, INC.EKR2024-06-27
00813677024985PDT, Inc.PDT, INC.EKR2024-06-27
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