FDA.report

EdgeBurs®

Primary DI
10818365024367
Brand
EdgeBurs®
Company
US ENDODONTICS, LLC
Model
FG330G100
Catalog number
FG330G100
Device description
Orca Metal Cutting Bur 330T 100pk Orca Turbo Carbide Metal Cutting 330T 100pk
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

Related Records

Contact Domains

Product Codes

CodeName
EJLBUR, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00818365024360PrimaryGS10
10818365024367Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00818365024360008183650243608183650243600818365024360
1081836502436710818365024367

GMDN Terms

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

Contacts

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 DIBrandModelCatalogPublished
10810047645358EdgeSequel UtopiaES150421SEES150421SE2023-07-28
10810047645365EdgeSequel UtopiaES150425SEES150425SE2023-07-28
10810047645372EdgeSequel UtopiaES150431SEES150431SE2023-07-28
10810047645389EdgeSequel UtopiaES250421SEES250421SE2023-07-28
10810047645396EdgeSequel UtopiaES250425SEES250425SE2023-07-28
10810047645402EdgeSequel UtopiaES250431SEES250431SE2023-07-28
10810047645419EdgeSequel UtopiaES300421SEES300421SE2023-07-28
10810047645426EdgeSequel UtopiaES300425SEES300425SE2023-07-28
10810047645433EdgeSequel UtopiaES300431SEES300431SE2023-07-28
10810047645440EdgeSequel UtopiaES400421SEES400421SE2023-07-28
10810047645457EdgeSequel UtopiaES400425SEES400425SE2023-07-28
10810047645464EdgeSequel UtopiaES400431SEES400431SE2023-07-28
10810047645471EdgeSequel UtopiaES500421SEES500421SE2023-07-28
10810047645488EdgeSequel UtopiaES500425SEES500425SE2023-07-28
10810047645495EdgeSequel UtopiaES500431SEES500431SE2023-07-28
10810047645501EdgeSequel UtopiaES250621SEES250621SE2023-07-28
10810047645518EdgeSequel UtopiaES250625SEES250625SE2023-07-28
10810047645525EdgeSequel UtopiaES250631SEES250631SE2023-07-28
10810047645532EdgeSequel UtopiaES300621SEES300621SE2023-07-28
10810047645549EdgeSequel UtopiaES300625SEES300625SE2023-07-28

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
D7717248LTF1Dental CityICP, INC.EJL2026-05-26
D7717270021Dental CityICP, INC.EJL2026-05-26
D7717270031Dental CityICP, INC.EJL2026-05-26
D7717270041Dental CityICP, INC.EJL2026-05-26
D7717270061Dental CityICP, INC.EJL2026-05-26
D7717270081Dental CityICP, INC.EJL2026-05-26
D7717270091Dental CityICP, INC.EJL2026-05-26
D7717271041Dental CityICP, INC.EJL2026-05-26
D7717271061Dental CityICP, INC.EJL2026-05-26
D7717271081Dental CityICP, INC.EJL2026-05-26
D7717271141Dental CityICP, INC.EJL2026-05-26
D7717272041Dental CityICP, INC.EJL2026-05-26
D7717272051Dental CityICP, INC.EJL2026-05-26
D7717272061Dental CityICP, INC.EJL2026-05-26
D7717272141Dental CityICP, INC.EJL2026-05-26
D7717272741Dental CityICP, INC.EJL2026-05-26
D7717273031Dental CityICP, INC.EJL2026-05-26
D7717273041Dental CityICP, INC.EJL2026-05-26
D7717273771Dental CityICP, INC.EJL2026-05-26
D7717273781Dental CityICP, INC.EJL2026-05-26
D7717273791Dental CityICP, INC.EJL2026-05-26
D7717274041Dental CityICP, INC.EJL2026-05-26
D7717274061Dental CityICP, INC.EJL2026-05-26
D7717274081Dental CityICP, INC.EJL2026-05-26
D7717275721Dental CityICP, INC.EJL2026-05-26
D7717275831Dental CityICP, INC.EJL2026-05-26
D7717276131Dental CityICP, INC.EJL2026-05-26
D7717276421Dental CityICP, INC.EJL2026-05-26
D7717276641Dental CityICP, INC.EJL2026-05-26
D7717276761Dental CityICP, INC.EJL2026-05-26