FDA.report

Advance Dental Products

Primary DI
00371347010992
Brand
Advance Dental Products
Company
The Atlanta Dental Supply Company
Model
555102
Device description
Fluoride Trays Single, Medium
Published
2023-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KMTTRAY, FLUORIDE, DISPOSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
KMTTray, Fluoride, DisposableDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10371347010999PrimaryGS10
00371347010992Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1037134701099910371347010999
00371347010992003713470109923713470109920371347010992

GMDN Terms

TermDefinition
Fluoride gel trayA device typically made of styrofoam that is used to apply fluoride topically to the teeth. The device is designed to conform to the human mouth; a patient bites down on the device after it has been filled with a fluoride gel or solution for application.

Sterilization Methods

Method

Regulatory Flags

DUNS number
033505389
Device count
100
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

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00371347022131Advance Dental ProductsPM018HC2026-01-15
00371347021028Advance Dental ProductsAPT1012026-01-15
00371347021035Advance Dental ProductsAPT1022026-01-15
00371347021042Advance Dental ProductsAPT1032026-01-15
00371347021059Advance Dental ProductsAPT1042026-01-15
00371347021066Advance Dental ProductsAPT1052026-01-15
00371347021073Advance Dental ProductsAPT1082026-01-15
00371347021080Advance Dental ProductsAPT1092026-01-15
00371347021097Advance Dental ProductsAPT1102026-01-15
00371347021103Advance Dental ProductsAPT1112026-01-15
00371347021110Advance Dental ProductsAPT1122026-01-15
00371347021127Advance Dental ProductsAPT1132026-01-15
00371347021134Advance Dental ProductsAPT1162026-01-15
00371347021141Advance Dental ProductsAPT1172026-01-15
00371347021158Advance Dental ProductsAPT1182026-01-15
00371347021165Advance Dental ProductsAPT1202026-01-15
00371347021172Advance Dental ProductsAPT1212026-01-15
00371347021189Advance Dental ProductsAPT1242026-01-15
00371347021196Advance Dental ProductsAPT1252026-01-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10889813067854Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067861Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067878Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067885Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067892Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067908Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067915Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067922Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067939Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067946Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067953Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00766054003007Turbo-CRESSENTIAL DENTAL SYSTEMS, INC.KMT2025-04-04
D956FLTRAY25Fluoride Gel Tray 25-pkD.S.I DENTAL SOLUTIONS LTDKMT2024-07-01
00810339031299SAFE DENTBGSS Company Inc.KMT2024-05-01
00810339031435SAFE DENTBGSS Company Inc.KMT2024-05-01
00810339031497SAFE DENTBGSS Company Inc.KMT2024-05-01
EFOR4080610001Track bleachForestadent Bernhard Förster GmbHKMT2023-08-11
00371347010947Advance Dental ProductsThe Atlanta Dental Supply CompanyKMT2023-03-08
00371347010954Advance Dental ProductsThe Atlanta Dental Supply CompanyKMT2023-03-08
00371347010961Advance Dental ProductsThe Atlanta Dental Supply CompanyKMT2023-03-08
00371347010978Advance Dental ProductsThe Atlanta Dental Supply CompanyKMT2023-03-08
00371347010985Advance Dental ProductsThe Atlanta Dental Supply CompanyKMT2023-03-08
00371347011005Advance Dental ProductsThe Atlanta Dental Supply CompanyKMT2023-03-08
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D0031300830NUPRO® Dentsply ProfessionalKMT2022-12-03
D687AD320100Topex® Sultan Healthcare IncKMT2022-12-03
D687AD320110Topex® Sultan Healthcare IncKMT2022-12-03