FDA.report

Dental City

Primary DI
D77133353BL1
Brand
Dental City
Company
ICP, INC.
Model
33-353BL
Device description
Dental City Barrier Film 4X6 Blue (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
D77133353BL1PrimaryHIBCC0

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
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

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