FDA.reportPublic FDA data

MANI PLUGGERS

Primary DI
04546951506148
Brand
MANI PLUGGERS
Company
MANI, INC.
Model
21mm #25
Device description
MANI PLUGGERS
Published
2022-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04546951506148PrimaryGS10
74546951506147Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546951506148045469515061484546951506148
7454695150614774546951506147

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
690622428
Device count
6
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14546951639997MANI MICRO FORCEPSSquare 25G 360 Grip 33mm2026-09-18
14546951640009MANI MICRO FORCEPSRound 25G 360 Grip 33mm2026-09-18
14546951640016MANI MICRO FORCEPSILM 25G 360 Grip 33mm2026-09-18
14546951640023MANI MICRO FORCEPSSquare 27G 360 Grip 33mm2026-09-18
14546951640030MANI MICRO FORCEPSRound 27G 360 Grip 33mm2026-09-18
14546951640047MANI MICRO FORCEPSILM 27G 360 Grip 33mm2026-09-18
14546951640054MANI MICRO FORCEPSEXFine 27G 360 Grip 33mm2026-09-18
14546951640061MANI MICRO FORCEPSSquare 25G 360 Grip 28mm2026-09-18
14546951640078MANI MICRO FORCEPSRound 25G 360 Grip 28mm2026-09-18
14546951640085MANI MICRO FORCEPSILM 25G 360 Grip 28mm2026-09-18
14546951640092MANI MICRO FORCEPSSquare 27G 360 Grip 28mm2026-09-18
14546951640108MANI MICRO FORCEPSRound 27G 360 Grip 28mm2026-09-18
14546951640115MANI MICRO FORCEPSILM 27G 360 Grip 28mm2026-09-18
14546951640122MANI MICRO FORCEPSEXFine 27G 360 Grip 28mm2026-09-18
14546951616721MANI Ophthalmic KnifeMSL24CH Slit-Angled 2.4mm CH2026-07-23
14546951627383MANI Ophthalmic KnifeMSL22CH Slit-Angled 2.2mm CH2026-07-23
14546951627390MANI Ophthalmic KnifeMSL27CH Slit-Angled 2.75mm CH2026-07-23
14546951638990MANI Ophthalmic KnifeMSL16MV-02 Slit Angled 1.6mm2026-04-23
14546951618787MANI TRABECULOTOMY HOOKMTH-S TRABECULOTOMY HOOK Straight Type2026-04-29
04546951534219MANI CARBIDE BURS6 (CA)2026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979865810038JAS MotorDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810045JAS FillDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810052JAS PexDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810069JAS ActivatorDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810076JAS Charging UnitDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810083JAS Contra-AngleDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810090JAS Power SupplyDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810106JAS Activator Ultrasonic TipsDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810113JAS Fill Gutta-Percha NeedlesDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810137JAS Heat Plugger TipDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810168JAS Pack Gutta-Percha CutterDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810175JAS Unit Endo SystemDENJOY DENTAL CO.,LTDEKR2026-09-24
G8791062850DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKR2026-08-08
G8791062880DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKR2026-08-08
08404535018981Brasseler USAPeter Brasseler Holdings, LLCEKR2026-06-26
00348783009002Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
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