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
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
00810339031282SAFE DENTBGSS Company Inc.KMT2024-05-01
00810339031428SAFE DENTBGSS Company Inc.KMT2024-05-01
00810339031480SAFE DENTBGSS Company Inc.KMT2024-05-01
00810339031299SAFE DENTBGSS Company Inc.KMT2024-05-01