FDA.reportPublic FDA data

Dental City

Primary DI
D77133353PK1
Brand
Dental City
Company
ICP, INC.
Model
33-353PK
Device description
Dental City Barrier Film 4X6 Pink (with dispenser box)
Published
2021-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
IWXBarrier, Control Panel, X-Ray, Movable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWXBarrier, Control Panel, X-Ray, MovableRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D77133353PK1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Implantable-device infection control barrierA sterile, bioabsorbable, implantable substance intended to be applied as a protective barrier over the surface of an implantable device (e.g., orthopaedic prosthesis) prior to implantation to prevent bacterial adhesion, colonization, and biofilm formation through physical means only; it may be used in conjunction with a separate antimicrobial agent. It contains microbe-derived materials [e.g., hyaluronic acid (HA)] and may be supplied in dry form (e.g., powder) intended to be hydrated prior to use; disposable devices associated with application/preparation (e.g., syringes, adaptors, application nozzle) may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
808371371
Device count
1
Premarket exempt
true
Lot or batch
true

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

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Primary DI, Brand, Company table
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00814907020579ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
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00814907020609ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
00814907020623ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-12
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00814907020463ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00814907020500ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
00814907020555ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
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