FDA.report

Dental City

Primary DI
D771393870
Brand
Dental City
Company
ICP, INC.
Model
39-387
Device description
K-Files 21mm #70
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
D77139387PrimaryHIBCC0
D771393870Unit 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
D77114705LG0Stratus14-705LG2026-03-24
D77114705MD0Stratus14-705MD2026-03-24
D77114705SM0Stratus14-705SM2026-03-24
D77114705XL0Stratus14-705XL2026-03-24
D77114705XS0Stratus14-705XS2026-03-24
D7714227200BG0Dental City42-27200BG42-27200BG2026-03-24
D7714227200M0Dental City42-27200M42-27200M2026-03-24
D7714227200ML0Dental City42-27200ML2026-03-24
D771422750ML0Dental City42-2750ML2026-03-24
D77116100LG0Guardian16-100LG2026-03-19
D77116100MD0Guardian16-100MD2026-03-19
D77116100SM0Guardian16-100SM2026-03-19
D77116100XL0Guardian16-100XL2026-03-19
D77116100XS0Guardian16-100XS2026-03-19
D77114701LG0Dental City14-701LG2023-06-02
D77114701MD0Dental City14-701MD2023-06-02
D77114701SM0Dental City14-701SM2023-06-02
D77114701XL0Dental City14-701XL2023-06-02
D77114701XS0Dental City14-701XS2023-06-02
D77114715LG0Dental City14-715LG2023-06-02

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