FDA.reportPublic FDA data

MG 04-15/40 LM

Primary DI
08806387809388
Brand
MG 04-15/40 LM
Company
Meta Biomed Co., Ltd.
Model
0938
Device description
MGP, Length Marked 04 Taper 15/40, 60 Points, P.71
Published
2025-08-26
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
08806387809388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806387809388088063878093888806387809388

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
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
08806387894049Metacem Set94042018-08-30
08806387894803Metapex Plus 0.894802021-04-16
08806387809395MG 06-15/40 LM09392025-08-26
08806387892090Meta Etchant92092016-09-19
08806387814603MX 02-1514602025-08-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810213814697EdgeEndo® EdgeCore™ for EdgeTaper™HSG-S Corp.EKM2026-08-19
00810213814703EdgeEndo® EdgeCore™ for EdgeTaper™HSG-S Corp.EKM2026-08-19
00810213814710EdgeEndo® EdgeCore™ for EdgeTaper™HSG-S Corp.EKM2026-08-19
00810213814727EdgeEndo® EdgeCore™ for EdgeTaper™HSG-S Corp.EKM2026-08-19
00810213814741EdgeEndo® EdgeFill™ for EdgeTaper™HSG-S Corp.EKM2026-08-19
00810213814758EdgeEndo® EdgeFill™ for EdgeTaper™HSG-S Corp.EKM2026-08-19
00810213814765EdgeEndo® EdgeFill™ for EdgeTaper™HSG-S Corp.EKM2026-08-19
00810213814789EdgeEndo® EdgeFill™ for EdgeTaper™HSG-S Corp.EKM2026-08-19
00810213814864EdgeEndo® EdgeCore™ for EdgeOne™HSG-S Corp.EKM2026-08-19
00810213814871EdgeEndo® EdgeCore™ for EdgeOne™HSG-S Corp.EKM2026-08-19
00810213814895EdgeEndo® EdgeCore™ for EdgeOne™HSG-S Corp.EKM2026-08-19
00810213814901EdgeEndo® EdgeFill™ for EdgeOne™HSG-S Corp.EKM2026-08-19
00810213814918EdgeEndo® EdgeFill™ for EdgeOne™HSG-S Corp.EKM2026-08-19
00810213814932EdgeEndo® EdgeFill™ for EdgeOne™HSG-S Corp.EKM2026-08-19
00810213814963EdgeEndo® EdgeCore™ for EdgeEndo®HSG-S Corp.EKM2026-08-19
00810213814970EdgeEndo® EdgeCore™ for EdgeEndo®HSG-S Corp.EKM2026-08-19
00810213815014EdgeEndo® EdgeFill™ for EdgeEndo®HSG-S Corp.EKM2026-08-19
00810213815045EdgeEndo® EdgeFill™ for EdgeEndo®HSG-S Corp.EKM2026-08-19
00810213815052EdgeEndo® EdgeFill™ for EdgeEndo®HSG-S Corp.EKM2026-08-19
00810213815106EdgeEndo® EdgeCore™ for EdgeEndo®HSG-S Corp.EKM2026-08-19
00810213815120EdgeEndo® EdgeCore™ for EdgeEndo®HSG-S Corp.EKM2026-08-19
00810213815168EdgeEndo® EdgeFill™ for EdgeEndo®HSG-S Corp.EKM2026-08-19
00810213814734EdgeEndo® EdgeCore™ for EdgeTaper™HSG-S Corp.EKM2026-08-18
00810213814772EdgeEndo® EdgeFill™ for EdgeTaper™HSG-S Corp.EKM2026-08-18
00810213814888EdgeEndo® EdgeCore™ for EdgeOne™HSG-S Corp.EKM2026-08-18
00810213814925EdgeEndo® EdgeFill™ for EdgeOne™HSG-S Corp.EKM2026-08-18
00810213814949EdgeEndo® EdgeCore™ for EdgeEndo®HSG-S Corp.EKM2026-08-18
00810213814956EdgeEndo® EdgeCore™ for EdgeEndo®HSG-S Corp.EKM2026-08-18
00810213814987EdgeEndo® EdgeCore™ for EdgeEndo®HSG-S Corp.EKM2026-08-18
00810213814994EdgeEndo® EdgeCore™ for EdgeEndo®HSG-S Corp.EKM2026-08-18