Manufacturer registered with FDA
US Endodontics, LLC
Johnson City, TN, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 79
- 510(k) clearances
- 0as applicant
- Markets registered in
- 8104 registrations outside the US
- Establishments
- 1United States
Registered in 8 markets
Where regulators' registries name US Endodontics, LLC as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | US Endodontics, LLC | 3 device types | — | Below |
| Canada | Health Canada | Registration holder | US ENDODONTICS | 59 | 2014–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | US Endodontics, LLC | 36 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | US Endodontics, LLC | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | US Endodontics LLC | 2 | 2021–2021 | Pure Global AI |
| South Korea | MFDS | Manufacturer | US EndodonticsUS Endodontics LLC | 2 | 2017–2022 | Pure Global AI |
| Japan | PMDA | Registration holder | ＵＳ Ｅｎｄｏｄｏｎｔｉｃｓ | 1 | 2025–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | US ENDODONTICS, LLC | 1 | 2017–2017 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What US Endodontics, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Burkhart VerifierChannels VerifierEdgeVerifyOneFill VerifierVTaper Verifier | 2011 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | AllFillBurkhart Hybrid Gutta CarrierBurkhart Thermal ObturatorChannels ObturatorChannels Snap-Off ObturatorEdgeCoreEdgeCore for Edge MorphologyEdgeCore for EdgeCoilEdgeCore for EdgeEvolveEdgeCore for EdgeOne 24 moreEdgeCore for EdgeSequel SapphireEdgeCore for EdgeTaperEdgeCore for EdgeTaper Encore PlatinumEdgeCore for EdgeTaper Platinum MISEdgeCore for EdgeV-FileEdgeCore for V-TaperEdgeCore ObturatorEdgeFillEdgeFill for Edge MorphologyEdgeFill for EdgeCoilEdgeFill for EdgeEvolveEdgeFill for EdgeOneEdgeFill for EdgeSequel SapphireEdgeFill for EdgeTaperEdgeFill for EdgeTaper Encore PlatinumEdgeFill for EdgeTaper Platinum MISEdgeFill for EdgeV-FileEdgeFill for V-TaperEdgeFill ObturatorGuttaFillOneFillTherma-KorUSEFillUSEFill Smart Core | 2011 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Channels FlexChannels OneChannels Performance Taper C SeriesChannels Performance Taper G seriesChannels PT C seriesChannels PT G seriesChannels RFEdge BroachesEdge C-FileEdge Hedstroms 30 moreEdge K-FileEdgeCoilEdgeCoil GlidePathEdgeEvolveEdgeFile X1EdgeFile X3EdgeFile X5EdgeFile X7EdgeFile XREdgeFindEdgeGatesEdgeGlidePathEdgeMorphologyEdgeOne FireEdgeOne Fire GlidePathEdgeOne GlidePathEdgeOne Glidepath MISEdgeOne PlatinumEdgeSequel SapphireEdgeTaperEdgeTaper Encore MISEdgeTaper Encore PlatinumEdgeTaper PlatinumEdgeTaper Platinum MISEdgeVTaperEdgeVTaper GlidePathEndoSequence Reciprocating FileEndoSequence VTScoutFlexiCONNIC | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| US Endodontics, LLCFDA reg. 3008857765 | Johnson City, TN, United States | Contract manufacturer, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10035363). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.