FDA.reportPublic FDA data

Gutta Percha points

Primary DI
J0030525160Z1
Brand
Gutta Percha points
Company
MAILLEFER INSTRUMENTS HOLDING Sàrl
Model
0525160Z
Catalog number
0525160Z
Published
2026-08-26
Public version status
Update
Distribution status
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
J0030525160Z1PrimaryHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00up to 86°F

Regulatory Flags#

DUNS number
480538495
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
false
Expiration date on label
false
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
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
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
J0030530MFZ1Gutta Percha Points GP0530MFZ0530MFZ2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970157003916Gutta Percha PointsTIANJIN GAPADENT CO., LTDEKM2026-10-30
06970157003947Gutta Percha PointsTIANJIN GAPADENT CO., LTDEKM2026-10-30
06970157003954Gutta Percha PointsTIANJIN GAPADENT CO., LTDEKM2026-10-30
06970157003961Gutta Percha PointsTIANJIN GAPADENT CO., LTDEKM2026-10-30
06970157003978Gutta Percha PointsTIANJIN GAPADENT CO., LTDEKM2026-10-30
06970157003985Gutta Percha PointsTIANJIN GAPADENT CO., LTDEKM2026-10-30
08809263708607MX 02-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263708614MX 02-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263708621MX 02-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263708638MX 02-30Meta Biomed Co., Ltd.EKM2026-10-28
08809263708645MX 02-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263708652MX 02-40Meta Biomed Co., Ltd.EKM2026-10-28
08809263708720MX 04-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263708737MX 04-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263708744MX 04-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263708751MX 04-30Meta Biomed Co., Ltd.EKM2026-10-28
08809263708768MX 04-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263708775MX 04-40Meta Biomed Co., Ltd.EKM2026-10-28
08809263708843MX 06-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263708850MX 06-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263708867MX 06-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263708874MX 06-30Meta Biomed Co., Ltd.EKM2026-10-28
08809263708881MX 06-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263708898MX 06-40Meta Biomed Co., Ltd.EKM2026-10-28
08809263708904MG 02-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263708911MG 02-20Meta Biomed Co., Ltd.EKM2026-10-28
08809263708928MG 02-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263708935MG 02-30Meta Biomed Co., Ltd.EKM2026-10-28
08809263708942MG 02-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263708959MG 02-40Meta Biomed Co., Ltd.EKM2026-10-28