FDA.reportPublic FDA data

Dental City

Primary DI
D771394080
Brand
Dental City
Company
ICP, INC.
Model
39-408
Device description
K-Files 25mm #55
Published
2021-07-15
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

Product Codes#

Code, Name table
CodeName
EKQPreparer, Root Canal Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKQPreparer, Root Canal EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D77139408PrimaryHIBCC0
D771394080Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic enlarger, single-useA non-sterile manual dental instrument designed to be used to access the root canal and to enlarge the opening of the coronal portion of the root canal. This is a single-use device.

Sterilization Methods#

Method table
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
TQ26126091141Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091161Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091181Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091201Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091221Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091241Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091261Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091281Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091301Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091321Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091341Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091361Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091381Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091401Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091421Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091441Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091461Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091471Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091481Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091491Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091501Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091511Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091521Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091531Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091541Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091551Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091561Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091571Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091581Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091591Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28