FDA.reportPublic FDA data

HEDY DENTAL DAM

Primary DI
10686864060427
Brand
HEDY DENTAL DAM
Company
AMD Medicom Inc
Model
320DNB-5M
Catalog number
320DNB-5M
Device description
"HEDY Polyisoprene Dental Dam - Non-Latex - 5""x 5"" - Medium - Blue"
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
20686864060424PackageGS140In Commercial Distribution
10686864060427PrimaryGS10
00686864060420Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686406042420686864060424
1068686406042710686864060427
00686864060420006868640604206868640604200686864060420

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam, non-latexA sheet of elastomeric synthetic material (e.g., silicone) 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 device may be used for patients and/or staff that have an allergy to latex. This is a single-use device.

Device Sizes#

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

Contacts#

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

Regulatory Flags#

DUNS number
256880576
Device count
30
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10686864061936MEDICOM ASSUREMASK VALIANT205915-B205915-B2026-03-17
10686864061943MEDICOM ASSUREMASK VALIANT205915-C205915-C2026-03-17
20686864061933MEDICOM ASSUREMASK VALIANT205915-B205915-B2026-03-17
20686864061940MEDICOM ASSUREMASK VALIANT205915-C205915-C2026-03-17
10686864060946MEDICOM DENTICARE 10067100672026-02-25
10686864060953MEDICOM DENTICARE 10068100682026-02-25
20686864060943MEDICOM DENTICARE 10067100672026-02-25
20686864060950MEDICOM DENTICARE 10068100682026-02-25
D8304405061PROFESSIONAL'S CHOICE4405064405062026-02-10
D8305514331MEDICOM5514335514332026-02-10
D8304405062PROFESSIONAL'S CHOICE4405064405062026-02-10
D8305514332MEDICOM5514335514332026-02-10
D830551432Generic5514322016-10-06
D830551434Generic5514342016-10-06
D830551436Generic5514362016-10-06
D830551438Generic5514382016-10-06
D830551440Generic5514402016-10-06
D830551442Generic5514422016-10-06
D8305604091Tyvek Self-Seal Pouch5604092025-01-02
D830560510Generic5605102016-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840161302694Insti-Dam® - Latex-Free Rubber Dam - 20 CountZIRC DENTAL PRODUCTS, INC.EIE2026-04-07
00840161302717Insti-Dam® - Latex-Free Rubber Dam - Relaxed Fit - 20 CountZIRC DENTAL PRODUCTS, INC.EIE2026-04-07
00840161304797Airway Armor® - Throat Guard - Small - 25 CountZIRC DENTAL PRODUCTS, INC.EIE2026-04-07
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
10686864060403HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060410HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060434HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060441HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
07630392910781HySolateDent4You AGEIE2024-07-11
07630392910972HySolateDent4You AGEIE2024-07-11
00630094043265Bioseal Inc.BIOSEALEIE2024-01-18
10732224005581Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005598Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005604Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005611Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005628Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005635Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005642Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20