FDA.reportPublic FDA data

HEDY DENTAL DAM

Primary DI
10686864060403
Brand
HEDY DENTAL DAM
Company
AMD Medicom Inc
Model
310DG-6T
Catalog number
310DG-6T
Device description
"HEDY DENTAL DAM - Natural Rubber Latex - 6"" x 6"" - Thin - Green"
Published
2024-08-27
Public version status
New
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
EIEDam, Rubber

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIEDam, RubberDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10686864060403PrimaryGS10
00686864060406Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068686406040310686864060403
00686864060406006868640604066868640604060686864060406

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam, Hevea-latexA sheet of elastomeric material made of Hevea natural rubber latex (NRL) that is punched with holes and placed over the teeth during dental procedures. It can have a variety of functions such as: 1) to isolate the field of operation from the rest of the oral cavity; 2) to eliminate saliva; 3) to prevent the patient swallowing liquid/dental material; 4) to protect soft tissue from harmful solutions; and 5) to reduce risk of infection. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

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

Regulatory Flags#

DUNS number
256880576
Device count
36
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains 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
08809262955514FineDamSpident Co., Ltd.EIE2026-10-07
D990ZVSADCK1PK0Single Arch Dam Conversion Kit 1PK, ZimVieSMART DENTURE CONVERSIONS, LLCEIE2026-06-26
06972902580062C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580079C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580093C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580109C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580116C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580123C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580130C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580147C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580154C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580161C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
07630392912129HySolateDent4You AGEIE2025-12-18
07630392912136HySolateDent4You AGEIE2025-12-18
10686864060298HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060304HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060311HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060328HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060335HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060342HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060359HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060366HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060373HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060380HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060397HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060410HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060427HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060434HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060441HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
07630392910781HySolateDent4You AGEIE2024-07-11