FDA.report

Dental City

Primary DI
D771394000
Brand
Dental City
Company
ICP, INC.
Model
39-400
Device description
K-Files 25mm #15
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

Related Records

Product Codes

CodeName
EKQPreparer, Root Canal Endodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EKQPreparer, Root Canal EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D77139400PrimaryHIBCC0
D771394000Unit of UseHIBCC0

GMDN Terms

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

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
00850440008407EDTAEngineered Endodontics, LLCEKQ2026-01-02
TQ26126091140Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091160Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091180Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091200Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091220Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091240Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091260Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091280Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091300Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091320Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091340Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091360Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091380Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091400Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091420Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091440Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091460Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091470Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091480Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091490Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091500Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091510Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091520Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091530Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091540Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091550Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091560Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091570Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091580Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28