FDA.reportPublic FDA data

MG 04-20

Primary DI
08809263709574
Brand
MG 04-20
Company
Meta Biomed Co., Ltd.
Model
0957
Device description
Smart Fit GP, Length Marked 04 Taper 20, 60 Points, P.91
Published
2026-10-28
Public version status
New
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
08809263709574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809263709574088092637095748809263709574

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
08809263708607MX 02-1508602026-10-28
08809263708614MX 02-2008612026-10-28
08809263708621MX 02-2508622026-10-28
08809263708638MX 02-3008632026-10-28
08809263708645MX 02-3508642026-10-28
08809263708652MX 02-4008652026-10-28
08809263708720MX 04-1508722026-10-28
08809263708737MX 04-2008732026-10-28
08809263708744MX 04-2508742026-10-28
08809263708751MX 04-3008752026-10-28
08809263708768MX 04-3508762026-10-28
08809263708775MX 04-4008772026-10-28
08809263708843MX 06-1508842026-10-28
08809263708850MX 06-2008852026-10-28
08809263708867MX 06-2508862026-10-28
08809263708874MX 06-3008872026-10-28
08809263708881MX 06-3508882026-10-28
08809263708898MX 06-4008892026-10-28
08809263708904MG 02-1508902026-10-28
08809263708911MG 02-2008912026-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08809263709567MG 04-15Meta Biomed Co., Ltd.EKM2026-10-28
08809263709581MG 04-25Meta Biomed Co., Ltd.EKM2026-10-28
08809263709598MG 04-30Meta Biomed Co., Ltd.EKM2026-10-28
08809263709604MG 04-35Meta Biomed Co., Ltd.EKM2026-10-28
08809263709611MG 04-40Meta Biomed Co., Ltd.EKM2026-10-28
08809263709680MG 06-15Meta Biomed Co., Ltd.EKM2026-10-28