FDA.reportPublic FDA data

Gutta Percha 04-LM-20

Primary DI
08806387804994
Brand
Gutta Percha 04-LM-20
Company
Meta Biomed Co., Ltd.
Model
0499
Device description
Gutta Percha Points and Bars Length Marked 04 taper #20, 60Points, P71
Published
2021-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
08806387804994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806387804994088063878049948806387804994

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688322841
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806387895190BeneMedik, 1~2mm, 30cc95192016-09-19
08806387895275BeneMedik, 4~6mm, 1cc95272016-09-19
08806387897002BoneMedik-DM, 0.1~0.3mm, 0.25g97002016-09-19
08806387897019BoneMedik-DM, 0.1~0.3mm, 0.5g97012016-09-19
08806387897026BoneMedik-DM, 0.1~0.3mm, 1.0g97022016-09-19
08806387897033Bonemedik-DM, 0.1~0.3mm, 2g97032016-09-19
08806387897040BoneMedik-DM, 0.1~0.3mm, 5g97042016-09-19
08806387897057BoneMedik-DM, 0.1~0.3mm, 10g97052016-09-19
08806387897064BoneMedik-DM 0.3~0.5mm, 0.25g97062016-09-19
08806387897071BoneMedik-DM, 0.3~0.5mm, 0.5g97072016-09-19
08806387897088BoneMedik-DM 0.3~0.5mm, 1.0g97082016-09-19
08806387897095BoneMedik-DM 0.3~0.5mm, 2.0g97092016-09-19
08806387897101BoneMedik-DM, 0.3~0.5mm, 5g97102016-09-19
08806387897118BoneMedik-DM, 0.3~0.5mm, 10g97112016-09-19
08806387897125BoneMedik-DM 0.5~1.0mm, 0.25g97122016-09-19
08806387897132BoneMedik-DM 0.5~1.0mm, 0.5g97132016-09-19
08806387897149BoneMedik-DM 0.5~1.0mm, 1.0g97142016-09-19
08806387897156BoneMedik-DM 0.5~1.0mm, 2.0g97152016-09-19
08806387897163BoneMedik-DM, 0.5~1mm, 5g97162016-09-19
08806387897170BoneMedik-DM, 0.5~1mm, 10g97172016-09-19

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