FDA.reportPublic FDA data

SAFE DENT

Primary DI
00810339031435
Brand
SAFE DENT
Company
BGSS Company Inc.
Model
A90142M
Device description
A90142M FLOURIDE TRAY DUAL ARCH "medium" BAG 100
Published
2024-05-01
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

Product Codes#

Code, Name table
CodeName
KMTTray, Fluoride, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMTTray, Fluoride, DisposableDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810339031435PackageGS110In Commercial Distribution
00810339031428PrimaryGS10
00810339031411Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810339031435008103390314358103390314350810339031435
00810339031428008103390314288103390314280810339031428
00810339031411008103390314118103390314110810339031411

GMDN Terms#

Term, Definition table
TermDefinition
Teeth whitening trayA custom-made device intended to retain a bleaching agent for whitening natural teeth through bleaching. It is made of polymer materials in the form of a mould to fit precisely over the teeth for a specified patient. This is a single-patient reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
828474952
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
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
00810339030100SAFE DENTP50192024-05-15
00810339030322SAFE DENTM3010BL2024-05-15
00810339031138SAFE DENTM3011PK2024-05-15
00810339031398SAFE DENTH501392024-05-15
00810339031657SAFE DENTH501382024-05-15
00810339031831SAFE DENTLAB201M-BL2024-05-15
00810339031862SAFE DENTLAB202L-BL2024-05-15
00810339031893SAFE DENTLAB203XL-BL2024-05-15
00854014003034SAFE DENTSTP-7001-A2024-05-15
00854014003065SAFE DENTSTP-7002-B2024-05-15
00854014003096SAFE DENTSTP-7003-C2024-05-15
00854014003126SAFE DENTSTP-7004-D2024-05-15
00854014003157SAFE DENTSTP-7004-E2024-05-15
00854014003188SAFE DENTSTP-7006-F2024-05-15
00854014003645SAFE DENTPT8112W2024-05-15
00854014003683SAFE DENTPT8113BL2024-05-15
00854014003720SAFE DENTPT8114DR2024-05-15
00854014003751SAFE DENTPT8115LV2024-05-15
00854014003812SAFE DENTPT8117MG2024-05-15
00810339030018SAFE DENTP50132024-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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
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
00371347010992Advance Dental ProductsThe Atlanta Dental Supply CompanyKMT2023-03-08
00371347011005Advance Dental ProductsThe Atlanta Dental Supply CompanyKMT2023-03-08
D687AD320120Topex® Sultan Healthcare IncKMT2022-12-05
D0031300800NUPRO® Dentsply ProfessionalKMT2022-12-03
D0031300810NUPRO® Dentsply ProfessionalKMT2022-12-03
D0031300820NUPRO® Dentsply ProfessionalKMT2022-12-03
D0031300830NUPRO® Dentsply ProfessionalKMT2022-12-03
D687AD320100Topex® Sultan Healthcare IncKMT2022-12-03
D687AD320110Topex® Sultan Healthcare IncKMT2022-12-03