FDA.reportPublic FDA data

Wedjets

Primary DI
D661H065241
Brand
Wedjets
Company
COLTENE/WHALEDENT INC
Model
H06524
Device description
Wedjet Small - Non-Latex
Published
2019-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EIEDam, Rubber

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIEDam, RubberDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K900844000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K900844000WEDJETSThe Hygenic Corp.1990-04-16EIE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D661H065241PrimaryHIBCC0
D661H065240Unit of UseHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius32 Degrees Celsius

Regulatory Flags#

DUNS number
622185718
Device count
42
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
D661R100699C1AlpenR100699C2026-06-05
D661XL848SC0161AlpenXL848SC0162019-02-12
D661R862C016FG1AlpenR862C016FG2019-02-11
D661R862EF010FG1AlpenR862EF010FG2019-02-11
D661R862EF012FG1AlpenR862EF012FG2019-02-11
D661R862F010FG1AlpenR862F010FG2019-02-11
D661R862F012FG1AlpenR862F012FG2019-02-11
D661R862F016FG1AlpenR862F016FG2019-02-11
D661R862SC014FG1AlpenR862SC014FG2019-02-11
D661R862UF010FG1AlpenR862UF010FG2019-02-11
D661R862UF012FG1AlpenR862UF012FG2019-02-12
D661R863C012FG1AlpenR863C012FG2019-02-12
D661R863EF012B1AlpenR863EF012B2019-02-11
D661R863EF012FG1AlpenR863EF012FG2019-02-12
D661R863EF016FG1AlpenR863EF016FG2019-02-12
D661R863F012FG1AlpenR863F012FG2019-02-11
D661R863F016FG1AlpenR863F016FG2019-02-11
D661R863SC016FG1AlpenR863SC016FG2019-02-11
D661R864F014FG1AlpenR864F014FG2019-02-11
D661R877C010FG1AlpenR877C010FG2019-02-12

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