FDA.reportPublic FDA data

Relief ACP

Primary DI
00075020089892
Brand
Relief ACP
Company
Discus Dental, LLC
Model
DIS571/99
Device description
Relief ACP Oral Care Gel, 1 Syr. Pack
Published
2019-09-24
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
00075020089892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00075020089892000750200898920750200898920075020089892

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
831726109
Device count
1
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
00075020043863Philips Relief ACP Oral Care GelDIS2728810272305402016-09-07
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
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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00850006606863Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606870Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606900Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606917Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606948Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606955Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606986Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
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