FDA.reportPublic FDA data

PASTINJECT

Primary DI
J015201210151
Brand
PASTINJECT
Company
MICRO MEGA
Model
n30 L25
Catalog number
20121015
Device description
Endodontic instrument for professionnal dental use only
Published
2020-08-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EIYInstrument, Filling, Plastic, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J015201210159PackageHIBCC10Not in Commercial Distribution
J015201210151PrimaryHIBCC0
J015201210150Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic obturation material distribution endpiece, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
276075371
Device count
4
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J015600406651MM K-Filesn006 L21 ISO M09600406652026-04-08
J015600406661MM K-Filesn008 L21 ISO M09600406662026-04-08
J015600406671MM K-Filesn010 L21 ISO M09600406672026-04-08
J015600406681MM K-Filesn015 L21 ISO M09600406682026-04-08
J015600406691MM K-Filesn020 L21 ISO M09600406692026-04-08
J015600406701MM K-Filesn025 L21 ISO M09600406702026-04-08
J015600406711MM K-Filesn030 L21 ISO M09600406712026-04-08
J015600406721MM K-Filesn035 L21 ISO M09600406722026-04-08
J015600406731MM K-Filesn040 L21 ISO M09600406732026-04-08
J015600406741MM K-Filesn045 L21 ISO M09600406742026-04-08
J015600406751MM K-Filesn050 L21 ISO M09600406752026-04-08
J015600406761MM K-Filesn055 L21 ISO M09600406762026-04-08
J015600406771MM K-Filesn060 L21 ISO M09600406772026-04-08
J015600406781MM K-Filesn070 L21 ISO M09600406782026-04-08
J015600406791MM K-Filesn080 L21 ISO M09600406792026-04-08
J015600406821MM K-Filesn006 L25 ISO M09600406822026-04-08
J015600406831MM K-Filesn008 L25 ISO M09600406832026-04-08
J015600406841MM K-Filesn010 L25 ISO M09600406842026-04-08
J015600406851MM K-Filesn015 L25 ISO M09600406852026-04-08
J015600406861MM K-Filesn020 L25 ISO M09600406862026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454001615COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454002681COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454002698COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004227COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004234COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004241COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004258COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004265COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004272COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004289COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004296COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004302COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454004319COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454006382COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454006399COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454006405COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454012024COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454014523COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454014530COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454014547COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015230COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015360COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015377COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015384COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015391COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015407COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015414COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015421COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015438COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27
06954454015445COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-27