FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813048573
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
9430204
Catalog number
9430204
Device description
TAKE HOME WHITENING RFL 15%CP
Published
2022-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAUERASER, DENTAL STAIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAUEraser, Dental StainDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889813048580PrimaryGS10
00889813048573Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813048580008898130485808898130485800889813048580
00889813048573008898130485738898130485730889813048573

GMDN Terms#

Term, Definition table
TermDefinition
Dental bleaching agentA dental liquid solution or a paste used to whiten teeth for therapeutic or cosmetic purposes. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(516)688-6800Robyn.livingston@darby.com

Regulatory Flags#

DUNS number
825137818
Device count
50
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889813067970Darby Dental Supply, LLC95377462026-03-22
00889813067987Darby Dental Supply, LLC95377502026-03-22
00889813067994Darby Dental Supply, LLC525879552587952026-02-12
00889813068007Darby Dental Supply, LLC525879652587962026-02-12
00889813068021Darby Dental Supply, LLC525879752587972026-02-12
00889813068038Darby Dental Supply, LLC525879852587982026-02-12
00889813068045Darby Dental Supply, LLC525879952587992026-02-12
00889813068052Darby Dental Supply, LLC525879052587902026-02-12
00889813068069Darby Dental Supply, LLC525879152587912026-02-12
00889813068076Darby Dental Supply, LLC525879252587922026-02-12
00889813068083Darby Dental Supply, LLC525879352587932026-02-12
00889813068090Darby Dental Supply, LLC525879452587942026-02-12
00889813048566Darby Dental Supply, LLC943020394302032022-07-18
00889813048580Darby Dental Supply, LLC943020494302042022-07-18
00889813048610Darby Dental Supply, LLC943020594302052022-07-18
00889813048672Darby Dental Supply, LLC943021094302102022-07-18
00889813048696Darby Dental Supply, LLC943021194302112022-07-18
00889813048719Darby Dental Supply, LLC943021294302122022-07-18
00889813048443Darby Dental Supply, LLC943020294302022022-07-18
00889813048511Darby Dental Supply, LLC943020194302012022-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860012825523SmileDirectClub Dissolving StripsOrtho Dental Lab LLCMAU2025-10-16
00860012825530SmileDirectClub Whitening Pen - 4 Pack Plus LightOrtho Dental Lab LLCMAU2025-10-16
00860012825547SmileDirectClub Whitening Refill - 8 PackOrtho Dental Lab LLCMAU2025-10-16
00860012825561SmileDirectClub Whitening plus Lip Balm - 4 PackOrtho Dental Lab LLCMAU2025-10-16
00850078989123SmileSet Premium Whitening Kit – BlackOrtho Dental Lab LLCMAU2025-09-25
00850078989130SmileSet Premium Whitening Kit – MintOrtho Dental Lab LLCMAU2025-09-25
00850078989147SmileSet Premium Whitening Kit – WhiteOrtho Dental Lab LLCMAU2025-09-25
00850078989154SmileSet Premium Whitening Refill – 4 PackOrtho Dental Lab LLCMAU2025-09-25
00850078989161SmileSet Premium Whitening Sample Pen – 3 mlOrtho Dental Lab LLCMAU2025-09-25
00850078989178SmileSet Premium Sensitive Whitening StripsOrtho Dental Lab LLCMAU2025-09-25
00353238006208Perio Sciences LED Tooth WhitenerPerio Sciences, LLCMAU2024-02-08
00353238106212Perio Sciences Replacement Tooth Whitening PensPerio Sciences, LLCMAU2024-02-08
06970016621824NonJiangxi Dentalbright Technology Co., LtdMAU2023-05-06
07506338301480MDC DentalMDC DENTALMAU2023-05-04
06970016623651DanielJiangxi Dentalbright Technology Co., LtdMAU2023-03-25
06970016621404GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016621534GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016621831GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016621879GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016622005GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016622807GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016622920GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016623057GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016623200GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016623293GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016624030GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016624481GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016624887GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016625006GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22