FDA.reportPublic FDA data

MX 02-15

Primary DI
08806387814603
Brand
MX 02-15
Company
Meta Biomed Co., Ltd.
Model
1460
Device description
Smart Fit GP, 02 Taper 15, 60 Points, P.91
Published
2025-08-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EKMGutta-Percha

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKMGutta-PerchaDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806387814603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806387814603088063878146038806387814603

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic gutta-perchaA dental material made from a polymer-based, synthetic gutta-percha containing fillers and radiopacifiers in a soft resin matrix, intended to fill the root canal of a tooth. This material has the ability to resist leakage significantly better than natural gutta-percha based obturation whilst strengthening the root resulting in roots having a coronal and apical seal as part of the canal filling process. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
688322841
Device count
1
DM exempt
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806387809388MG 04-15/40 LM09382025-08-26
08806387809395MG 06-15/40 LM09392025-08-26
08806387814610MX 02-2014612025-08-26
08806387814627MX 02-2514622025-08-26
08806387814634MX 02-3014632025-08-26
08806387814641MX 02-3514642025-08-26
08806387814658MX 02-4014652025-08-26
08806387814665MX 04-1514662025-08-26
08806387814672MX 04-2014672025-08-26
08806387814689MX 04-2514682025-08-26
08806387814696MX 04-3014692025-08-26
08806387814702MX 04-3514702025-08-26
08806387814719MX 04-4014712025-08-26
08806387814726MX 06-1514722025-08-26
08806387814733MX 06-2014732025-08-26
08806387814740MX 06-2514742025-08-26
08806387814757MX 06-3014752025-08-26
08806387814764MX 06-3514762025-08-26
08806387814771MX 06-4014772025-08-26
08806387814788MG 02-15 LM14782025-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10817417020197Dentsply SironaASEPTICO, INC.EKM2026-09-28
06979865810120JAS Gutta-Percha PelletsDENJOY DENTAL CO.,LTDEKM2026-09-24
J0030525020Z1Gutta Percha Points ISOMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525025Z1Gutta Percha Points ISOMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525030Z1Gutta Percha Points ISOMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525035Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525040Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525045Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525050Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525055Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525060Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525160Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525165Z1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530F1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FF1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FFZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FM1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FMZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530L1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530M1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530MF1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530MFZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530MZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530XF1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530XFM1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541FL1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541FM1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541FS1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541L1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26