FDA.reportPublic FDA data

MANI ENGINE REAMERS

Primary DI
74546951513541
Brand
MANI ENGINE REAMERS
Company
MANI, INC.
Model
18mm #45-80
Device description
MANI ENGINE REAMERS
Published
2022-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EKPREAMER, PULP CANAL, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKPReamer, Pulp Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546951513542PrimaryGS10
74546951513541Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546951513542045469515135424546951513542
7454695151354174546951513541

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic file/rasp, reusableA dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. 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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
74546951616426MANI MICRO FORCEPSSquare Type 27G2026-03-03
74546951616433MANI MICRO FORCEPSRound Type 27G2026-03-03
74546951616440MANI MICRO FORCEPSEXFine Type 27G2026-03-03
74546951619090MANI MICRO FORCEPSSquare Type 25G2026-03-03
74546951619106MANI MICRO FORCEPSRound Type 25G2026-03-03
74546951635595MANI MICRO FORCEPSILM 25G Slim Grip 33mm2026-03-03
74546951635601MANI MICRO FORCEPSILM 27G Slim Grip 33mm2026-03-03
74546951635618MANI MICRO FORCEPSSquare 25G Slim Grip 28mm2026-03-03
74546951635625MANI MICRO FORCEPSRound 25G Slim Grip 28mm2026-03-03
74546951635632MANI MICRO FORCEPSILM 25G Slim Grip 28mm2026-03-03
74546951635649MANI MICRO FORCEPSSquare 27G Slim Grip 28mm2026-03-03
74546951635656MANI MICRO FORCEPSRound 27G Slim Grip 28mm2026-03-03
74546951635663MANI MICRO FORCEPSILM 27G Slim Grip 28mm2026-03-03
74546951635670MANI MICRO FORCEPSEXFine 27G Slim Grip 28mm2026-03-03
74546951635687MANI MICRO FORCEPSSquare 25G Wide Grip 33mm2026-03-03
74546951635694MANI MICRO FORCEPSRound 25G Wide Grip 33mm2026-03-03
74546951635700MANI MICRO FORCEPSILM 25G Wide Grip 33mm2026-03-03
74546951635717MANI MICRO FORCEPSSquare 27G Wide Grip 33mm2026-03-03
74546951635724MANI MICRO FORCEPSRound 27G Wide Grip 33mm2026-03-03
74546951635731MANI MICRO FORCEPSILM 27G Wide Grip 33mm2026-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D6620708732570PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708732650PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708732730PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708733800PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708733980PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708734060PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708736610PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708738770PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708738850PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708739430PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708739500PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708740810PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763180PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763260PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763340PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763420PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763750PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
05060940375786Lentulo, 25, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375793Lentulo, 30, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375809Lentulo, 35, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375816Lentulo, 40, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375823Lentulo, 25-40, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940379333Lentulo 25-40, 21ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375410Gates Gliddens, 1, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375427Gates Gliddens, 2, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375434Gates Gliddens, 3, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375441Gates Gliddens, 4, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375458Gates Gliddens, 5, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375465Gates Gliddens, 6, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375472Gates Gliddens, 1-6, 28ENDOPERFECTION LIMITEDEKP2023-12-11