FDA.reportPublic FDA data

Endodontic Hand Instruments

Primary DI
D716821250250
Brand
Endodontic Hand Instruments
Company
TULSA DENTAL PRODUCTS LLC
Model
82125025
Catalog number
82125025
Device description
BRASSELER REAMERS 25/25
Published
2022-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
false

Product Codes#

Code, Name table
CodeName
EKPREAMER, PULP CANAL, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKPReamer, Pulp Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D716821250251PrimaryHIBCC0
D716821250250Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual endodontic file/rasp, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
942778564
Device count
6
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
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
D716PUENDO11ProUltraPUENDO1PUENDO12016-10-07
D716PUENDO151ProUltraPUENDO1-5PUENDO1-52016-11-11
D716PUENDO21ProUltraPUENDO2PUENDO22016-10-07
D716PUENDO31ProUltraPUENDO3PUENDO32016-10-07
D716PUENDO41ProUltraPUENDO4PUENDO42016-10-07
D716PUENDO51ProUltraPUENDO5PUENDO52016-10-07
D716PUENDO61ProUltraPUENDO6PUENDO62016-10-07
D716PUENDO681ProUltraPUENDO6-8PUENDO6-82016-11-11
D716PUENDO71ProUltraPUENDO7PUENDO72016-10-07
D716PUENDO81ProUltraPUENDO8PUENDO82016-10-07
D716PUSINE11ProUltraPUSINE1PUSINE12016-10-07
D716PUSINE161ProUltra SINEPUSINE1-6PUSINE1-62016-11-11
D716PUSINE21ProUltraPUSINE2PUSINE22016-10-07
D716PUSINE31ProUltra SINEPUSINE3PUSINE32016-10-07
D716PUSINE41ProUltra SINEPUSINE4PUSINE42016-10-07
D716PUSINE51ProUltra SINEPUSINE5PUSINE52016-10-07
D716PUSINE61ProUltra SINEPUSINE6PUSINE62016-10-07
D716PUSURG11ProUltraPUSURG1PUSURG12016-10-07
D716PUSURG161ProUltraPUSURG1-6PUSURG1-62016-11-11
D716PUSURG21ProUltraPUSURG2PUSURG22016-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D6620708732570PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708732650PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708732730PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708733800PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708733980PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708734060PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708736610PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708738770PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708738850PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708739430PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708739500PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708740810PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763180PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763260PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763340PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763420PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
D6620708763750PattersonPATTERSON DENTAL SUPPLY, INC.EKP2024-11-11
05060940375786Lentulo, 25, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375793Lentulo, 30, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375809Lentulo, 35, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375816Lentulo, 40, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375823Lentulo, 25-40, 29ENDOPERFECTION LIMITEDEKP2024-03-29
05060940379333Lentulo 25-40, 21ENDOPERFECTION LIMITEDEKP2024-03-29
05060940375410Gates Gliddens, 1, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375427Gates Gliddens, 2, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375434Gates Gliddens, 3, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375441Gates Gliddens, 4, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375458Gates Gliddens, 5, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375465Gates Gliddens, 6, 28ENDOPERFECTION LIMITEDEKP2023-12-11
05060940375472Gates Gliddens, 1-6, 28ENDOPERFECTION LIMITEDEKP2023-12-11