Primary Device ID | 10818365025166 |
NIH Device Record Key | 6ca716e5-e2e5-4789-95d8-9f78f3b5b785 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EdgeBurs® |
Version Model Number | FG558SURG10 |
Catalog Number | FG558SURG10 |
Company DUNS | 061317427 |
Company Name | US ENDODONTICS, LLC |
Device Count | 5 |
DM Exempt | true |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(423)283-0047 |
Bobby.bennett@us-endo.com | |
Phone | +1(423)283-0047 |
Bobby.bennett@us-endo.com | |
Phone | +1(423)283-0047 |
Bobby.bennett@us-endo.com | |
Phone | +1(423)283-0047 |
Bobby.bennett@us-endo.com | |
Phone | +1(423)283-0047 |
Bobby.bennett@us-endo.com | |
Phone | +1(423)283-0047 |
Bobby.bennett@us-endo.com | |
Phone | +1(423)283-0047 |
Bobby.bennett@us-endo.com | |
Phone | +1(423)283-0047 |
Bobby.bennett@us-endo.com | |
Phone | +1(423)283-0047 |
Bobby.bennett@us-endo.com | |
Phone | +1(423)283-0047 |
Bobby.bennett@us-endo.com | |
Phone | +1(423)283-0047 |
Bobby.bennett@us-endo.com | |
Phone | +1(423)283-0047 |
Bobby.bennett@us-endo.com | |
Phone | +1(423)283-0047 |
Bobby.bennett@us-endo.com | |
Phone | +1(423)283-0047 |
Bobby.bennett@us-endo.com | |
Phone | +1(423)283-0047 |
Bobby.bennett@us-endo.com | |
Phone | +1(423)283-0047 |
Bobby.bennett@us-endo.com | |
Phone | +1(423)283-0047 |
Bobby.bennett@us-endo.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00818365025169 [Primary] |
GS1 | 10818365025166 [Unit of Use] |
EJL | BUR, DENTAL |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-03 |
Device Publish Date | 2023-06-25 |
10818365025531 | Zirconia Wheel Shine Long Straight Shank – HP Fine sterile roll 25 |
10818365025524 | Zirconia Wheel Polish Long Straight Shank – HP Medium sterile roll 25 |
10818365025517 | Zirconia Small Point Shine Right Angle – RA Fine sterile roll 25 |
10818365025500 | Zirconia Small Point Polish Right Angle – RA Medium sterile roll 25 |
10818365025494 | Zirconia Large Point Shine Right Angle – RA Fine sterile roll 25 |
10818365025487 | Zirconia Large Point Shine Long Straight Shank – HP Fine sterile roll 25 |
10818365025470 | Zirconia Large Point Polish Right Angle – RA Medium sterile roll 25 |
10818365025463 | Zirconia Large Point Polish Long Straight Shank – HP Medium sterile roll 25 |
10818365025456 | Zirconia Knife Edge Shine Right Angle – RA Fine sterile roll 25 |
10818365025449 | Zirconia Knife Edge Shine Long Straight Shank – HP Fine sterile roll 25 |
10818365025432 | Zirconia Knife Edge Polish Right Angle – RA Medium sterile roll 25 |
10818365025425 | Zirconia Knife Edge Polish Long Straight Shank – HP Medium sterile roll 25 |
10818365025418 | Zirconia Cup Shine Right Angle – RA Fine sterile roll 25 |
10818365025401 | Zirconia Cup Polish Right Angle – RA Medium sterile roll 25 |
10818365025395 | Operative Carbide Bur RA 8 100 pk Round RA 8 100 pk |
10818365025388 | Operative Carbide Bur RA 7 10pk Round RA 7 10pk |
10818365025371 | Operative Carbide Bur RA 2 100 pk Round RA 2 100 pk |
10818365025364 | Operative Carbide Bur RA 1172 10pk 8 Flutes RA 1172 10pk |
10818365025357 | Operative Carbide Bur RA 1172 100 pk 9 Flutes RA 1172 100 pk |
10818365025333 | Operative Carbide Bur PR1-T COLOR BAND 10pk Orca Turbo Carbide Metal Cutting Bur PR1-T COLOUR |
10818365025326 | Operative Carbide Bur HP 8 5pk Round HP 8 5pk |
10818365025319 | Operative Carbide Bur HP 8 100 pk Round HP 8 100 pk |
10818365025302 | Operative Carbide Bur HP 703 5pk Taper Fissure Cross Cut HP 703 5pk |
10818365025296 | Operative Carbide Bur HP 703 100 pk Taper Fissure Cross Cut HP 703 100 pk |
10818365025289 | Operative Carbide Bur HP 702 5pk Taper Fissure Cross Cut HP 702 5pk |
10818365025272 | Operative Carbide Bur HP 702 100 pk Taper Fissure Cross Cut HP 702 100 pk |
10818365025265 | Operative Carbide Bur HP 701 5pk Taper Fissure Cross Cut HP 701 5pk |
10818365025258 | Operative Carbide Bur HP 6 5pk Round HP 6 5pk |
10818365025241 | Operative Carbide Bur HP 5 5pk Round HP 5 5pk |
10818365025234 | Operative Carbide Bur HP 4 5pk Round HP 4 5pk |
10818365025227 | Operative Carbide Bur HP 2 5pk Round HP 2 5pk |
10818365025210 | Operative Carbide Bur FG SL 701 10pk Taper Fissure Cross Cut FG SL 701 10pk |
10818365025203 | Operative Carbide Bur FG 701 10pk Taper Fissure Cross Cut FG 701 10pk |
10818365025197 | Operative Carbide Bur FG 701 100 pk Taper Fissure Cross Cut FG 701 100 pk |
10818365025180 | Operative Carbide Bur FG 58 10pk Flat Fissure Plain Cut FG 58 10pk |
10818365025173 | Operative Carbide Bur FG 56 10pk Flat Fissure Plain Cut FG 56 10pk |
10818365025166 | Operative Carbide Bur FG 558 SURG 10pk Flat Fissure Cross Cut FG 558 SURG 10pk |
10818365025159 | Operative Carbide Bur FG 556 SS 10pk Flat Fissure Cross Cut FG 556 10pk |
10818365025142 | Operative Carbide Bur FG 556 SS 100 pk Flat Fissure Cross Cut FG 556 100 pk |
10818365025135 | Operative Carbide Bur FG 37 10pk Inverted Cone FG 37 10pk |
10818365025128 | Operative Carbide Bur FG 169 10pk Taper Fissure Plain Cut FG 169 10pk |
10818365025104 | Operative Carbide Bur FG 1172 100 pk 8 Flutes FG 1172 100 pk |
10818365025098 | Operative Carbide Bur FG 1157 10pk Domed Fissure Plain Cut FG 1157 10pk |
10818365025081 | Operative Carbide Bur FG 699 10pk Taper Fissure Cross Cut FG 699 10pk |
10818365025074 | Finishing Carbide Bur OF 2 (OS 2) 5pk Safe End Taper 12 Blade OF 2 (OS 2) 5pk |
10818365025067 | Operative Carbide Bur FG 170 10pk Taper Fissure Plain Cut FG 170 10pk |
10818365025050 | Operative Carbide Bur FG 1157 100 pk Domed Fissure Plain Cut FG 1157 100 pk |
10818365025043 | Operative Carbide Bur FG 331L 10pk Pear Long FG 331L 10pk |
10818365025029 | Operative Carbide Bur RA 5 10pk Round RA 5 10pk |
10818365025012 | Operative Carbide Bur FG 700 10pk Taper Fissure Cross Cut FG 700 10pk |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EDGEBURS 90498524 not registered Live/Pending |
Edge Endo, LLC 2021-01-29 |