FDA.report

Dental City

Primary DI
D77139PESA0
Brand
Dental City
Company
ICP, INC.
Model
39-PESA
Device description
Peeso Reamers Assorted 28mm Short
Published
2021-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EKPReamer, Pulp Canal, Endodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EKPReamer, Pulp Canal, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D77139PESA1PrimaryHIBCC0
D77139PESA0Unit of UseHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
808371371
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 DIBrandModelCatalogPublished
D7717248LTF1Dental City72-48LTF2026-05-26
D7717270021Dental City72-70022026-05-26
D7717270031Dental City72-70032026-05-26
D7717270041Dental City72-70042026-05-26
D7717270061Dental City72-70062026-05-26
D7717270081Dental City72-70082026-05-26
D7717270091Dental City72-70092026-05-26
D7717271041Dental City72-71042026-05-26
D7717271061Dental City72-71062026-05-26
D7717271081Dental City72-71082026-05-26
D7717271141Dental City72-71142026-05-26
D7717272041Dental City72-72042026-05-26
D7717272051Dental City72-72052026-05-26
D7717272061Dental City72-72062026-05-26
D7717272141Dental City72-72142026-05-26
D7717272741Dental City72-72742026-05-26
D7717273031Dental City72-73032026-05-26
D7717273041Dental City72-73042026-05-26
D7717273771Dental City72-73772026-05-26
D7717273781Dental City72-73782026-05-26

Other Devices Sharing Product Codes

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