FDA.reportPublic FDA data

MANI PASTE CARRIERS

Primary DI
04546951515744
Brand
MANI PASTE CARRIERS
Company
MANI, INC.
Model
29mm #25-40
Device description
MANI PASTE CARRIERS
Published
2022-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKSFILE, PULP CANAL, ENDODONTIC

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546951515744PrimaryGS10
74546951515743Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546951515744045469515157444546951515744
7454695151574374546951515743

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic obturation material distribution endpiece, reusableA dental endpiece designed to be attached to a dental power tool handpiece to distribute root canal sealer/cement/paste evenly throughout the root canal system typically by applying the material in a lateral direction. It is a thin metal rod with a spiral (e.g., Lentulo spiral type), helicoidal, or circular design. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
690622428
Device count
4
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
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
04546951601447MANI CARBIDE BURS1/4 (CA)2026-04-08
04546951601454MANI CARBIDE BURS1/2 (CA)2026-04-08
04546951601461MANI CARBIDE BURS1 (CA)2026-04-08
04546951601478MANI CARBIDE BURS2 (CA)2026-04-08
04546951601485MANI CARBIDE BURS3 (CA)2026-04-08
04546951601492MANI CARBIDE BURS4 (CA)2026-04-08
04546951601508MANI CARBIDE BURS5 (CA)2026-04-08
04546951601515MANI CARBIDE BURS7 (CA)2026-04-08
04546951601522MANI CARBIDE BURS8 (CA)2026-04-08
04546951400729MANI Sutures Polyester337833782016-06-04
04546951400750MANI Sutures Polyester337533752016-06-04
04546951400767MANI Sutures Polyester337433742016-06-04
04546951400859MANI Sutures Polyester337333732016-06-04
04546951401429MANI Sutures Polyester141214122016-06-04
04546951402662MANI Sutures Polyester337133712016-06-04
04546951402679MANI Sutures Polyester337033702016-06-04
04546951400538MANI Sutures Polyester435743572016-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941877830090EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-06-09
06941877830106EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-06-09
06941877830113EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-06-09
07640452461030EdgeGlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461047EdgeGlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461054EdgeGlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461061EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461078EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461085EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461092EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461108EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461115EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461122EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461139EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461146EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461153EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461160EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461177EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461184EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461191EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461207EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461214EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461221EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461238EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461245EdgeOne GlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461252EdgeOne GlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461269EdgeOne GlidepathFKG Dentaire SàrlEKS2026-06-03
07640452462235EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462242EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462259EdgeTaperFKG Dentaire SàrlEKS2026-06-03