Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008857765

FEI Number

3008857765

Entity Name

US Endodontics, LLC

City/State/Country

Johnson City, TN, US

Establishment Address

2809 W. Walnut St, Johnson City, TN 37604, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

US Endodontics, LLC (Owner Number: 10035363)

Owner / Operator Contact Address

2809 W. Walnut Street, Johnson City, TN 37604, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Burkhart Verifier VTaper Verifier Channels Verifier OneFill Verifier EdgeVerify EdgeGlidePath EndoSequence Reciprocating File EdgeCoil GlidePath EdgeOne Platinum Channels One NIC EdgeOne Fire GlidePath Edge Hedstroms EdgeFile X5 EdgeFile X7 EdgeOne Glidepath MIS EdgeFile X3 EdgeTaper Encore MIS EdgeCoil EdgeEvolve EdgeTaper Encore Platinum Edge Broaches Channels Performance Taper C Series Channels Flex Edge K-File EdgeTaper Platinum EdgeFind EdgeMorphology EdgeSequel Sapphire EdgeOne Fire EndoSequence VTScout FlexiCON EdgeTaper Channels PT C series EdgeOne GlidePath EdgeFile XR EdgeFile X1 Channels RF EdgeTaper Platinum MIS EdgeGates EdgeVTaper Channels PT G series Edge C-File Channels Performance Taper G series EdgeVTaper GlidePath Therma-Kor EdgeFill for EdgeCoil OneFill AllFill EdgeCore for EdgeTaper Burkhart Hybrid Gutta Carrier EdgeCore for EdgeCoil EdgeFill for Edge Morphology EdgeCore for V-Taper EdgeCore for Edge Morphology GuttaFill EdgeFill for EdgeTaper Encore Platinum EdgeFill EdgeCore Obturator EdgeCore for EdgeSequel Sapphire EdgeFill for EdgeTaper Platinum MIS Channels Obturator EdgeCore for EdgeV-File EdgeFill for EdgeOne EdgeFill for EdgeEvolve EdgeCore for EdgeTaper Platinum MIS EdgeCore for EdgeOne EdgeCore for EdgeTaper Encore Platinum Burkhart Thermal Obturator Channels Snap-Off Obturator USEFill USEFill Smart Core EdgeFill for EdgeSequel Sapphire EdgeCore for EdgeEvolve EdgeFill for EdgeV-File EdgeFill Obturator EdgeFill for EdgeTaper EdgeCore EdgeFill for V-Taper

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2011-02-23
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2013-05-06
EKM	Gutta-Percha	Dental	Class 1	872.3850	2011-02-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

US Endodontics, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27

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3009161350	PALTOP ADVANCED DENTAL SOLUTIONS LTD	Caesarea Central, IL
3032027578	Solventum Orthodontics Corporation	Monrovia, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008857765. Last updated year: 2026. Please use registration number 3008857765 when referencing this establishment in official correspondence.