FDA.reportPublic FDA data

EdgeBurs®

Primary DI
10818365024312
Brand
EdgeBurs®
Company
US ENDODONTICS, LLC
Model
FG3410
Catalog number
FG3410
Device description
Operative Carbide Bur FG 34 10pk Inverted Cone FG 34 10pk
Published
2023-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818365024315PrimaryGS10
10818365024312Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818365024315008183650243158183650243150818365024315
1081836502431210818365024312

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, single-useA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(423)283-0047Bobby.bennett@us-endo.com

Regulatory Flags#

DUNS number
061317427
Device count
5
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00810047645351EdgeSequel UtopiaES150421SEES150421SE2023-07-28
00810047645368EdgeSequel UtopiaES150425SEES150425SE2023-07-28
00810047645375EdgeSequel UtopiaES150431SEES150431SE2023-07-28
00810047645382EdgeSequel UtopiaES250421SEES250421SE2023-07-28
00810047645399EdgeSequel UtopiaES250425SEES250425SE2023-07-28
00810047645405EdgeSequel UtopiaES250431SEES250431SE2023-07-28
00810047645412EdgeSequel UtopiaES300421SEES300421SE2023-07-28
00810047645429EdgeSequel UtopiaES300425SEES300425SE2023-07-28
00810047645436EdgeSequel UtopiaES300431SEES300431SE2023-07-28
00810047645443EdgeSequel UtopiaES400421SEES400421SE2023-07-28
00810047645450EdgeSequel UtopiaES400425SEES400425SE2023-07-28
00810047645467EdgeSequel UtopiaES400431SEES400431SE2023-07-28
00810047645474EdgeSequel UtopiaES500421SEES500421SE2023-07-28
00810047645481EdgeSequel UtopiaES500425SEES500425SE2023-07-28
00810047645498EdgeSequel UtopiaES500431SEES500431SE2023-07-28
00810047645504EdgeSequel UtopiaES250621SEES250621SE2023-07-28
00810047645511EdgeSequel UtopiaES250625SEES250625SE2023-07-28
00810047645528EdgeSequel UtopiaES250631SEES250631SE2023-07-28
00810047645535EdgeSequel UtopiaES300621SEES300621SE2023-07-28
00810047645542EdgeSequel UtopiaES300625SEES300625SE2023-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ESUNC1623160165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2025-04-29
07630049901384C141 Allport bone cutterDiaswiss SAEJL2023-10-02
07630049901612DIA-ZDiaswiss SAEJL2023-10-02
07630049902077Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951051Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951075Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951532Carbide bur Diacarb FG HCDiaswiss SAEJL2023-10-02
07630049951556FG Diacarb finishing bur HCDiaswiss SAEJL2023-10-02
07630049951921C141 Allport bone cutterDiaswiss SAEJL2023-10-02
07630049951983Carbide bur Diacarb RA HCDiaswiss SAEJL2023-10-02
07630049952003Carbide finishing bur Diacarb RADiaswiss SAEJL2023-10-02
07630049952041FG Diacarb carbide crown cutterDiaswiss SAEJL2023-10-02
07630049952065Carbide bur Diacarb FG HCDiaswiss SAEJL2023-10-02
07630049952089FG Diacarb finishing burDiaswiss SAEJL2023-10-02
07630049952164FG Diacarb finishing burDiaswiss SAEJL2023-10-02
07630049952188FG Diacarb finishing burDiaswiss SAEJL2023-10-02
ESUNC283K3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-25
ESUNC33L3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC33L3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040185Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040275Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCTR323140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC463140145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07