FDA.reportPublic FDA data

EdgeEndo® EdgeVerify™

Primary DI
00810213814840
Brand
EdgeEndo® EdgeVerify™
Company
HSG-S Corp.
Model
X74506V
Device description
Endodontic Verifier
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
EILGAUGE, DEPTH, INSTRUMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810213814840PrimaryGS10
80810213814846Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810213814840008102138148408102138148400810213814840
8081021381484680810213814846

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
6
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
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
00810213814697EdgeEndo® EdgeCore™ for EdgeTaper™ET2006C2026-08-19
00810213814703EdgeEndo® EdgeCore™ for EdgeTaper™ET2506C2026-08-19
00810213814710EdgeEndo® EdgeCore™ for EdgeTaper™ET3006C2026-08-19
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
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
00810213814796EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814802EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814819EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814833EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814857EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-19
00810213814826EdgeEndo® EdgeVerify™HSG-S Corp.EIL2026-08-18
00810135961233ToejackNVision Biomedical Technologies, Inc.EIL2026-07-29
G149TBSB1270TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4230TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4240TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4250TBS BASICSACME ENTERPRISE.EIL2026-05-20
G149TBSB4260TBS BASICSACME ENTERPRISE.EIL2026-05-20
J003SVN620451Thermafil Plus size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-04-17
J003SVN650901Thermafil Plus size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-04-17
J003VXSV620451Vortex Size VerifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-04-17
J0036692981Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693001Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693011Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693021Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693031Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693041Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693051Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693061Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693071Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J0036693081Densfil size verifiersMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF11Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF21Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF31Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF41Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26
J003PTGSVF51Protaper Gold Size VerifierMAILLEFER INSTRUMENTS HOLDING SàrlEIL2026-03-26