FDA.reportPublic FDA data

GuttaCore for WaveOne Gold Endodontic Instruments Size Verifiers

Primary DI
J003TNSGCWG625SML1
Brand
GuttaCore for WaveOne Gold Endodontic Instruments Size Verifiers
Company
MAILLEFER INSTRUMENTS HOLDING Sàrl
Model
TNSGCWG625SML
Catalog number
TNSGCWG625SML
Published
2026-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EILGAUGE, DEPTH, INSTRUMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J003TNSGCWG625SML1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual endodontic file/rasp, single-useA hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. 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 an endodontic reamer. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No storage/handling found

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480538495
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J0030525020Z1Gutta Percha Points ISO0525020Z0525020Z2026-08-26
J0030525025Z1Gutta Percha Points ISO0525025Z0525025Z2026-08-26
J0030525030Z1Gutta Percha Points ISO0525030Z0525030Z2026-08-26
J0030525035Z1Gutta Percha points0525035Z0525035Z2026-08-26
J0030525040Z1Gutta Percha points0525040Z0525040Z2026-08-26
J0030525045Z1Gutta Percha points0525045Z0525045Z2026-08-26
J0030525050Z1Gutta Percha points0525050Z0525050Z2026-08-26
J0030525055Z1Gutta Percha points0525055Z0525055Z2026-08-26
J0030525060Z1Gutta Percha points0525060Z0525060Z2026-08-26
J0030525160Z1Gutta Percha points0525160Z0525160Z2026-08-26
J0030525165Z1Gutta Percha Points GP0525165Z0525165Z2026-08-26
J0030530F1Gutta Percha Points GP0530F0530F2026-08-26
J0030530FF1Gutta Percha Points GP0530FF0530FF2026-08-26
J0030530FFZ1Gutta Percha Points GP0530FFZ0530FFZ2026-08-26
J0030530FM1Gutta Percha Points GP0530FM0530FM2026-08-26
J0030530FMZ1Gutta Percha Points GP0530FMZ0530FMZ2026-08-26
J0030530FZ1Gutta Percha Points GP0530FZ0530FZ2026-08-26
J0030530L1Gutta Percha Points GP0530L0530L2026-08-26
J0030530M1Gutta Percha Points GP0530M0530M2026-08-26
J0030530MF1Gutta Percha Points GP0530MF0530MF2026-08-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D955BMDG021Paul BandittTerlain Enterprises, Inc.EIL2026-09-25
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00810213814796EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814802EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814819EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814833EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814840EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814857EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814826EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-18
00810135961233ToejackNVision Biomedical Technologies, Inc.EIL2026-07-29
G149TBSB1270TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4230TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4240TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4250TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4260TBS BASICSACME ENTERPRISE.EIL2026-05-20
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