FDA.reportPublic FDA data

SAFE DENT

Primary DI
00810339031282
Brand
SAFE DENT
Company
BGSS Company Inc.
Model
A90143L
Device description
"A90143L FLOURIDE TRAY DUAL ARCH ""large"" Bag 100"
Published
2024-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00810339031299PackageGS110In Commercial Distribution
00810339031282PrimaryGS10
00810339031275Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810339031299008103390312998103390312990810339031299
00810339031282008103390312828103390312820810339031282
00810339031275008103390312758103390312750810339031275

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.

Regulatory Flags#

DUNS number
828474952
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854014003263SAFE DENTC60112024-05-01
00854014003294SAFE DENTC60122024-05-01
00854014003331SAFE DENTC60132024-05-01
00854014003362SAFE DENTCF60142024-05-01
00810339030001SAFE DENTP50132024-05-01
00810339030032SAFE DENTP5016XL2024-05-01
00810339030063SAFE DENTP50102024-05-01
00810339030094SAFE DENTP50192024-05-15
00810339030124SAFE DENTP50142024-05-01
00810339030162SAFE DENTP5015XL2024-05-01
00810339030193SAFE DENTP50182024-05-01
00810339030483SAFE DENTB2010W2024-05-01
00810339030506SAFE DENTB2011BL2024-05-01
00810339030520SAFE DENTB2012DR2024-05-01
00810339030544SAFE DENTB2013MG2024-05-01
00810339030568SAFE DENTB2014LV2024-05-01
00810339030582SAFE DENTB2015P2024-05-01
00810339030605SAFE DENTB2016Y2024-05-01
00810339030926SAFE DENTBF90167C2024-05-01
00810339030957SAFE DENTBF90166B2024-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850043381570Buffalo DentalBuffalo Dental Manufacturing Co., Inc.KMT2026-04-10
00850043381587Buffalo DentalBuffalo Dental Manufacturing Co., Inc.KMT2026-04-10
00889813067857Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067864Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067871Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067888Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067895Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067901Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067918Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067925Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067932Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067949Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067956Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
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
00810339031428SAFE DENTBGSS Company Inc.KMT2024-05-01
00810339031480SAFE DENTBGSS Company Inc.KMT2024-05-01
00810339031299SAFE DENTBGSS Company Inc.KMT2024-05-01
00810339031435SAFE DENTBGSS Company Inc.KMT2024-05-01