FDA.reportPublic FDA data

BARBED BROACHES

Primary DI
07640142421221
Brand
BARBED BROACHES
Company
FKG Dentaire Sàrl
Model
03.050.31.025.CT
Catalog number
03.050.31.025.CT
Device description
Barbed Broaches 50, 31 mm, # 25, handle CT
Published
2022-08-14
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

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
07640142421221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640142421221076401424212217640142421221

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic broach, serrated, single-useA hand-held, manual, dental, cutting instrument with a slender, tapered, serrated/barbed tip intended to be used for shaping and enlarging holes in root canal tissue, particularly dentine, or for extirpating pulp. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
482884061
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640452465588Edge File X3X3170421HTSX3170421HTS2025-12-05
07640452465595Edge File X3X3200421HTSX3200421HTS2025-12-05
07640452465656Edge File X3X3170425HTSX3170425HTS2025-12-05
07640452465724Edge File X3X3170429HTSX3170429HTS2025-12-05
07640452465809Edge File X3X3200621HTSX3200621HTS2025-12-05
07640452465816Edge File X3X3250621HTSX3250621HTS2025-12-05
07640452465823Edge File X3X3300621HTSX3300621HTS2025-12-05
07640452465830Edge File X3X3400621HTSX3400621HTS2025-12-05
07640452465861Edge File X3X3200625HTSX3200625HTS2025-12-05
00764045246587Edge File X3X3250625HTSX3250625HTS2025-12-05
07640452465885Edge File X3X3300625HTSX3300625HTS2025-12-05
07640452465908Edge File X3X3400625HTSX3400625HTS2025-12-05
07640452466684Edge File X3X3170629HTSX3170629HTS2025-12-05
07640452465939Edge File X3X3200629HTSX3200629HTS2025-12-05
07640452465946Edge File X3X3250629HTSX3250629HTS2025-12-05
07640452465953Edge File X3X3300629HTSX3300629HTS2025-12-05
07640452465977Edge File X3X3400629HTSX3400629HTS2025-12-05
07640452466660Edge File X3X321ASSTX321ASST2025-12-05
07640452466677Edge File X3X325ASSTX325ASST2025-12-05
07640452466004EdgeSequel SapphireES04153021ASSTES04153021ASST2025-11-28

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