FDA.reportPublic FDA data

SPIRAL FILLERS

Primary DI
J015201220141
Brand
SPIRAL FILLERS
Company
MICRO MEGA
Model
n45 L25
Catalog number
20122014
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
J015201220149PackageHIBCC10Not in Commercial Distribution
J015201220141PrimaryHIBCC0
J015201220140Unit 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
G149TBSB4010TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4020TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4030TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4040TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4050TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4060TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4070TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4080TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4140TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4150TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4200TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4210TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4220TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB8130TBS BASICSACME ENTERPRISE.EIY2026-05-18
G149TBSB8010TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149TBSB8020TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149TBSB8030TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149TBSB8040TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149NPBPT0NPSACME ENTERPRISE.EIY2026-05-01
08800075626134OSUNG MNDOSUNG MND Co., Ltd.EIY2025-11-03
07649988072451OdneFill TipOdne AGEIY2024-02-01
10889950005283HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005290HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005306HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005313HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005320HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005337HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005344HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005351HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005368HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12