FDA.reportPublic FDA data

FineDam

Primary DI
08809262955514
Brand
FineDam
Company
Spident Co., Ltd.
Model
FineDam x 4ea
Device description
FineDam is a light-reflecting resin barrier for isolating tissue adjacent to teeth being whitened. For single tooth bleaching, FineDam may be used to protect adjacent teeth.
Published
2026-10-07
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

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
08809262955514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809262955514088092629555148809262955514

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.

Regulatory Flags#

DUNS number
689370711
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809262954302Soft Prep101-1401101-14012017-02-20
08809262950823OrthoFitOrthoFit Bond mini2026-07-14
08809262957983OrthoFitOrthoFit Bond 2ea2026-07-14
08809262957990OrthoFitOrthoFit Splint2026-07-14
08809262953602EsCemEsCem A22026-04-29
08809262953619EsCemEsCem A32026-04-29
08809262953626EsCemEsCem TW2026-04-29
08809262959000Temro.FlowTemp it Flow+ yellow 4ea2026-04-28
08809262959017Temro.FlowTemp it Flow+ Blu 4ea2026-04-28
08809262953206EsCom250EsCom250 A1#3203A12026-04-21
08809262953213EsCom250EsCom250 A2#3203A22026-04-21
08809262953220EsCom250EsCom250 A3#3203A32026-04-21
08809262953237EsCom250EsCom250 A3.5#3203A352026-04-21
08809262953244EsCom250EsCom250 A4#3203A42026-04-21
08809262953251EsCom250EsCom250 B1#3203B12026-04-21
08809262953268EsCom250EsCom250 B2#3203B22026-04-21
08809262953275EsCom250EsCom250 C2#3203C22026-04-21
08809262953282EsCom250EsCom250 D2#3203D22026-04-21
08809262953299EsCom250EsCom250 G1#3203G12026-04-21
08809262953305EsCom250EsCom250 AO2#3203AO22026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10686864060403HEDY 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