FDA.report

Dental City

Primary DI
D77133353CL1
Brand
Dental City
Company
ICP, INC.
Model
33-353CL
Device description
Dental City Barrier Film 4X6 Clear (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
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
IWXBarrier, Control Panel, X-Ray, Movable

Product Code Classifications

CodeDeviceSpecialtyClass
IWXBarrier, Control Panel, X-Ray, MovableRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D77133353CL1PrimaryHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
808371371
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

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