FDA.reportPublic FDA data

Dental City

Primary DI
D771391787
Brand
Dental City
Company
ICP, INC.
Model
39-1787
Device description
Barbed Broaches Medium 10/Pack Green
Published
2021-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
D771391787PrimaryHIBCC0
D7713917870Unit of UseHIBCC0

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.

Regulatory Flags#

DUNS number
808371371
Device count
10
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D771349300101Dental City34-9300102026-05-27
D771349300201Dental City34-9300202026-05-27
D771349300301Dental City34-9300302026-05-27
D771349300401Dental City34-9300402026-05-27
D771349300501Dental City34-9300502026-05-27
D771349300601Dental City34-9300602026-05-27
D771349300701Dental City34-9300702026-05-27
D771349300801Dental City34-9300802026-05-27
D771349300901Dental City34-9300902026-05-27
D771349301001Dental City34-9301002026-05-27
D771349301101Dental City34-9301102026-05-27
D771349301201Dental City34-9301202026-05-27
D771349301301Dental City34-9301302026-05-27
D771349301401Dental City34-9301402026-05-27
D771349301501Dental City34-9301502026-05-27
D771349320101Dental City34-9320102026-05-27
D771349320201Dental City34-9320202026-05-27
D771349320301Dental City34-9320302026-05-27
D771349320401Dental City34-9320402026-05-27
D771349320501Dental City34-9320502026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D6620708761021PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761101PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761281PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761361PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761441PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761511PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761691PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
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