FDA.report

Kool-Dam

Primary DI
D701PDB2
Brand
Kool-Dam
Company
PULPDENT CORPORATION
Model
PDB
Device description
Light cure, heatless liquid dam. BULK PACK: 10 x 3 mL syringes
Published
2021-09-21
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
false

Related Records

Product Codes

CodeName
EIEDam, Rubber

Product Code Classifications

CodeDeviceSpecialtyClass
EIEDam, RubberDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D701PDB2PrimaryHIBCC0

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
001006089
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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

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D701T20G191Applicator TipsT20G192024-12-03
D701SVBFUS2ACTIVA™ BioACTIVE Bulk FlowS-VBFUS2024-12-02
D701SVKBFUS2ACTIVA™ Kids BioACTIVE Bulk FlowS-VKBFUS2024-12-02
D701VBF1US2ACTIVA™ BioACTIVE Bulk FlowVBF1US2024-12-02
D701VKBF1OW2ACTIVA™ Kids BioACTIVE Bulk FlowVKBF1OW2024-12-02
D710VKBF1US2ACTIVA™ Kids BioACTIVE Bulk FlowVKBF1US2024-12-02
D701SUNO2DENTASTIC UNO SAMPLESUNO2018-08-10
D701SVPFA32Activa PrestoS-VPFA32023-06-22
D701SVPFA352Activa PrestoS-VPFA352023-06-22
D701SVPFA42Activa PrestoS-VPFA42023-06-22
D701SVPFA62Activa PrestoS-VPFA62023-06-22
D701SVPFB12Activa PrestoS-VPFB12023-06-22
D701TTP502Tuff Temp Plus Provisional Veneer, Crown, and Bridge ResinTTP502018-12-14
D701TTP50A12TUFF-TEMP PLUSTTP50A12019-11-22
D701TTP50A1X2TUFF-TEMP PLUSTTP50A1X2019-11-22
D701TTP50A22TUFF-TEMP PLUSTTP50A22019-11-22
D701TTP50A2X2TUFF-TEMP PLUSTTP50A2X2019-11-22
D701TTP50A32TUFF-TEMP PLUSTTP50A32019-11-22

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