FDA.reportPublic FDA data

EdgeBroaches™

Primary DI
10818365026262
Brand
EdgeBroaches™
Company
US ENDODONTICS, LLC
Model
EB4XF021
Catalog number
EB4XF021
Device description
EdgeBroaches™ #0; 21 mm
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
EKWBROACH, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKWBroach, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818365026265PrimaryGS10
10818365026262Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818365026265008183650262658183650262650818365026265
1081836502626210818365026262

GMDN Terms#

Term, Definition table
TermDefinition
Manual endodontic file/rasp, single-useA hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as an endodontic reamer. 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
10
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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D6620708761020PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761100PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761280PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761360PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761440PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761510PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761690PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
05060940375236Barbed Broaches, 0, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375243Barbed Broaches, 1, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375250Barbed Broaches, 2, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375267Barbed Broaches, 3, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375274Barbed Broaches, 4, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375281Barbed Broaches, 5, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375298Barbed Broaches, 6, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375304Barbed Broaches, 2-4, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375311Barbed Broaches, 0-6, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375328Barbed Broaches, 0, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375335Barbed Broaches, 1, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375342Barbed Broaches, 2, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375359Barbed Broaches, 3, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375366Barbed Broaches, 4, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375373Barbed Broaches, 5, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375380Barbed Broaches, 6, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375397Barbed Broaches, 2-4, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375403Barbed Broaches, 0-6, 25ENDOPERFECTION LIMITEDEKW2023-12-12
07630049992429Barbed broaches 31mm 025-040, pu: 12 pDiaswiss SAEKW2023-12-01
07630049992443Barbed broaches 31mm 025-060, pu: 12 pDiaswiss SAEKW2023-12-01
D6919053631Premier Barbed BroachesPREMIER DENTAL PRODUCTS COMPANYEKW2023-10-17
D6919053633Premier Barbed BroachesPREMIER DENTAL PRODUCTS COMPANYEKW2023-10-17
D6919053634Premier Barbed BroachesPREMIER DENTAL PRODUCTS COMPANYEKW2023-10-17