FDA.reportPublic FDA data

MEDICOM DENTICARE PRO-TRAY

Primary DI
10686864047701
Brand
MEDICOM DENTICARE PRO-TRAY
Company
AMD Medicom Inc
Model
10029-L
Catalog number
10029-L
Device description
MEDICOM DENTICARE DISPOSABLE FUORIDE GEL TRAY
Published
2019-01-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
20686864047708PackageGS115In Commercial Distribution
10686864047701PrimaryGS10
00686864047704Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686404770820686864047708
1068686404770110686864047701
00686864047704006868640477046868640477040686864047704

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Cool dry place

Contacts#

Phone, Email table
PhoneEmail
+1(514)636-6262mdasilva@medicom.ca
+1(514)636-6262mkansou@medicom.ca

Regulatory Flags#

DUNS number
256880576
Device count
50
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10686864061998Ocean Pacific NeoNatural1229-B1229-B2026-06-29
10686864062001Ocean Pacific NeoNatural1229-C1229-C2026-06-29
10686864062018Ocean Pacific NeoNatural1229-D1229-D2026-06-29
10686864062032Ocean Pacific NeoNatural1229B-SP61229B-SP62026-06-29
10686864062049Ocean Pacific NeoNatural1229C-SP61229C-SP62026-06-29
10686864062056Ocean Pacific NeoNatural1229D-SP61229D-SP62026-06-29
10686864016110Medicom AssureTouch9998-E9998-E2022-09-28
10686864029110Medicom AssureTouch9999-A9999-A2022-09-28
10686864048876AMD-RITMED SOLON55900559002023-07-10
10686864053955Medicom AssureTouch9950-C9950-C2022-09-28
10686864053962Medicom AssureTouch9950-D9950-D2022-09-28
10686864053979Medicom AssureTouch9950-E9950-E2022-09-28
10686864053986Medicom AssureTouch9950-F9950-F2022-09-28
10686864055058Medicom AssureTouch9950-B9950-B2022-09-28
10686864060113Medicom AssureTouch9985-A9985-A2023-07-27
10686864060120Medicom AssureTouch9985-B9985-B2023-07-27
10686864060137Medicom AssureTouch9985-C9985-C2023-07-27
10686864060144Medicom AssureTouch9985-D9985-D2023-07-27
10686864060151Medicom AssureTouch9985-E9985-E2023-07-27
20686864021661AMD-RITMED5100-B5100-B2019-01-17

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