FDA.reportPublic FDA data

Philips Relief ACP Oral Care Gel

Primary DI
00075020043863
Brand
Philips Relief ACP Oral Care Gel
Company
Discus Dental, LLC
Model
DIS272
Catalog number
881027230540
Device description
Relief ACP Oral Care Gel, 4 Syr. Refill Kit
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LBHVARNISH, CAVITY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062176000RELIEF ACP ORAL CARE GELDiscus Dental, Inc.2007-01-10LBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00075020043863PrimaryGS10
00075020065797Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00075020043863000750200438630750200438630075020043863
00075020065797000750200657970750200657970075020065797

GMDN Terms#

Term, Definition table
TermDefinition
Dental coating, tooth-desensitizingA substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
831726109
Device count
4
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08710103611967Philips Zoom! Protective EyewearDIS2038810203303002020-09-20
00075020035011Philips Zoom! WhiteSpeed Whitening LED AcceleratorDIS5588810558015402020-09-23
08710103632085Philips Zoom! WhiteSpeed IsoPrep RetractorDIS5738810573010202020-08-28
08710103632092Philips Zoom! IsoPrep RetractorDIS5748810574010202020-08-28
08710103632061Philips Zoom! Chairside Light-Activated Whitening KitDIS57148810571010202019-06-21
00075020035004Philips Zoom! Chairside Light-Activated Whitening KitDIS5578810557015402016-09-07
00075020065469Philips Zoom! Relief ACP Oral Care GelDIS4558810455015402016-09-07
00075020034991Philips Zoom! Chairside Light-Activated Whitening KitDIS5568810556015402016-09-07
00075020043900Relief ACPDIS445/012016-09-07
00075020044129Philips ZoomDIS716/012020-08-28
00075020089892Relief ACPDIS571/992019-09-24
08710103632122Philips ZoomDIS578/012020-09-23
00075020034311DASHDIS429/012016-09-07
00075020034403Relief ACPDIS455/022016-09-07
00075020034236Philips Sonicare BreathRxDIS442/012020-08-28
00075020034243Philips Sonicare BreathRxDIS442/022020-08-28
00075020048004Philips Sonicare BreathRxDIS251/012020-08-28
00075020048035Philips Sonicare BreathRxDIS357/032020-08-28
00075020048042Philips Sonicare BreathRxDIS357/112020-08-28
00075020048059Philips Sonicare BreathRxDIS359/032020-08-28

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