EdgeBurs® Z198016M
GUDID 10818365020468
Round End Taper Z198016M Diamond Round End Taper 25pk
US ENDODONTICS, LLC
Diamond dental bur, single-use| Primary Device ID | 10818365020468 |
| NIH Device Record Key | 1d7be059-a670-4f5f-9c4b-ffefb903edfd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EdgeBurs® |
| Version Model Number | Z198016M |
| Catalog Number | Z198016M |
| Company DUNS | 061317427 |
| Company Name | US ENDODONTICS, LLC |
| Device Count | 25 |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818365020461 [Primary] |
| GS1 | 10818365020468 [Unit of Use] |
FDA Product Code
| EJL | BUR, DENTAL |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10818365020468]
Radiation Sterilization
[10818365020468]
Radiation Sterilization
[10818365020468]
Radiation Sterilization
[10818365020468]
Radiation Sterilization
[10818365020468]
Radiation Sterilization
[10818365020468]
Radiation Sterilization
[10818365020468]
Radiation Sterilization
[10818365020468]
Radiation Sterilization
[10818365020468]
Radiation Sterilization
[10818365020468]
Radiation Sterilization
[10818365020468]
Radiation Sterilization
[10818365020468]
Radiation Sterilization
[10818365020468]
Radiation Sterilization
[10818365020468]
Radiation Sterilization
[10818365020468]
Radiation Sterilization
[10818365020468]
Radiation Sterilization
[10818365020468]
Radiation Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-03 |
| Device Publish Date | 2023-06-25 |
On-Brand Devices [EdgeBurs®]
| 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 |
Trademark Results [EdgeBurs]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EDGEBURS 90498524 not registered Live/Pending |
Edge Endo, LLC 2021-01-29 |
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