FDA.report

HYGENIC

Primary DI
D661H00534C1
Brand
HYGENIC
Company
COLTENE/WHALEDENT INC
Model
H00534C
Catalog number
H00534C
Device description
HYG. DENTAL DAM MED. L.
Published
2021-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EIEDam, Rubber

Product Code Classifications

CodeDeviceSpecialtyClass
EIEDam, RubberDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D661H00534C1PrimaryHIBCC0

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
622185718
Device count
1
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D661R100332C0AlpenR100332C2026-03-02
10840016202053CanalProENDOBUNDLEXMOV2026-02-10
D66160021987R0BioSonic60021987-R2026-01-08
D661600403880BioSonic600403882026-01-08
D66160040389S0BioSonic60040389S2026-01-08
D661600403920BioSonic600403922026-01-08
D661600403930BioSonic600403932026-01-08
D661600403970BioSonic600403972026-01-08
D66160040470S0BioSonic60040470S2026-01-08
D661H099451HygenicH099452019-02-11
D66160040390S1BioSonic60040390S2025-07-15
00840016202025BioSonic600403332025-02-20
00840016202032BioSonic600403342025-02-20
00840016202049BioSonic600403302025-02-20
D661H083711HyflexH083712019-02-11
D661H083721HyflexH083722019-02-26
D661H083741HyflexH083742019-02-12
D661H083761HyflexH083762019-02-11
D661H083781HyflexH083782019-02-26
D661H083801HyflexH083802019-02-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840161311689Insti-Dam® - Latex-Free Rubber Dam - Relaxed Fit - 1 Count Sample PackZIRC DENTAL PRODUCTS, INC.EIE2026-02-19
00840161311702Insti-Dam® - Latex-Free Rubber Dam - 1 Count Sample PackZIRC DENTAL PRODUCTS, INC.EIE2026-02-19
00840161311740Airway Armor® - Throat Guard - 3 Count Sample PackZIRC DENTAL PRODUCTS, INC.EIE2026-02-19
00840456203835JMUJMU DENTAL, INCEIE2025-12-22
00840456203842JMUJMU DENTAL, INCEIE2025-12-22
07630392912112HySolateDent4You AGEIE2025-12-18
17630392912126HySolateDent4You AGEIE2025-12-18
17630392912133HySolateDent4You AGEIE2025-12-18
D990SD10PK0Silicone Dam 10PKSmart Denture Conversions, LLCEIE2025-05-19
00359883001353True™ Dental Dam Latex Free 5x5DEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001360True™ Dental Dam Latex Free 6x6DEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001377True™ Dental Dam Latex Free 5x5 Heavy GaugeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001384True™ Dental Dam Latex 6x6DEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001391True™ Dental Dam Latex 6x6 Heavy GaugeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001407True™ Dental Dam Latex 5x5DEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001414True™ Dental Dam Latex 5x5 Heavy GaugeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001438True™ Dental Dam Latex Free 6x6 Heavy SampleDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883001445True™ Dental Dam Latex 6x6 Sample PackDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006648True™ Dental Dam Latex Free 6x6 Heavy GaugeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006679EdgeDam™ Refill Heavy 5x5 LatexDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006686EdgeDam™ Refill Heavy 5x5 Latex-FreeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006693EdgeDam™ Refill Heavy 6x6 LatexDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006709EdgeDam™ Refill Heavy 6x6 Latex-FreeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006716EdgeDam™ Refill Medium 5x5 LatexDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006723EdgeDam™ Refill Medium 5x5 Latex-FreeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006730EdgeDam™ Refill Medium 6x6 LatexDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006747EdgeDam™ Refill Medium 6x6 Latex-FreeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006754EdgeDam™ Sample Heavy 6x6 Latex-FreeDEN-MAT HOLDINGS, LLCEIE2025-03-12
00359883006761EdgeDam™ Sample Medium 6x6 LatexDEN-MAT HOLDINGS, LLCEIE2025-03-12
06972902583537C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2025-01-23