FDA.reportPublic FDA data

EdgeEndo® EdgeCore™ for EdgeTaper™

Primary DI
00810213814710
Brand
EdgeEndo® EdgeCore™ for EdgeTaper™
Company
HSG-S Corp.
Model
ET3006C
Device description
Endodontic Gutta Percha Core Obturator & Verifier Set
Published
2026-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
00810213814710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810213814710008102138147108102138147100810213814710

GMDN Terms#

Term, Definition table
TermDefinition
Warm-bonded endodontic obturation system obturatorA hand-held manual dental instrument designed for direct warm bonding during an endodontic obturation procedure. It is preloaded (encased) with a resin-based sealing, filling, and core material at its distal working end which is subsequently heated in a dedicated oven to a specified temperature prior to delivery of the materials into a root canal. It is available in a variety of root canal sizes. This is a single-use device.

Regulatory Flags#

DUNS number
144949235
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00810213814697EdgeEndo® EdgeCore™ for EdgeTaper™ET2006C2026-08-19
00810213814703EdgeEndo® EdgeCore™ for EdgeTaper™ET2506C2026-08-19
00810213814727EdgeEndo® EdgeCore™ for EdgeTaper™ET4006C2026-08-19
00810213814741EdgeEndo® EdgeFill™ for EdgeTaper™ET2006O2026-08-19
00810213814758EdgeEndo® EdgeFill™ for EdgeTaper™ET2506O2026-08-19
00810213814765EdgeEndo® EdgeFill™ for EdgeTaper™ET3006O2026-08-19
00810213814789EdgeEndo® EdgeFill™ for EdgeTaper™ET5006O2026-08-19
00810213814796EdgeEndo® EdgeVerify™X72006V2026-08-19
00810213814802EdgeEndo® EdgeVerify™X72506V2026-08-19
00810213814819EdgeEndo® EdgeVerify™X73006V2026-08-19
00810213814833EdgeEndo® EdgeVerify™X74006V2026-08-19
00810213814840EdgeEndo® EdgeVerify™X74506V2026-08-19
00810213814857EdgeEndo® EdgeVerify™X75006V2026-08-19
00810213814864EdgeEndo® EdgeCore™ for EdgeOne™EOPSM20C2026-08-19
00810213814871EdgeEndo® EdgeCore™ for EdgeOne™EOPPRI25C2026-08-19
00810213814895EdgeEndo® EdgeCore™ for EdgeOne™EOPLG45C2026-08-19
00810213814901EdgeEndo® EdgeFill™ for EdgeOne™EOPSM20O2026-08-19
00810213814918EdgeEndo® EdgeFill™ for EdgeOne™EOPPRI25O2026-08-19
00810213814932EdgeEndo® EdgeFill™ for EdgeOne™EOPLG45O2026-08-19
00810213814963EdgeEndo® EdgeCore™ for EdgeEndo®X73006C2026-08-19

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
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
00810213815007EdgeEndo® EdgeCore™ for EdgeEndo®HSG-S Corp.EKM2026-08-18