FDA.reportPublic FDA data

Hygenic

Primary DI
D661H027610
Brand
Hygenic
Company
COLTENE/WHALEDENT INC
Model
H02761
Device description
Hygenic Dam Clamp - #2
Published
2019-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EEFClamp, Rubber Dam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EEFClamp, Rubber DamDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D661H027610PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam clampA dental device with a buccal and lingual wing, or flange, used to anchor a rubber dam down to the cervical region of an exposed tooth. This device comes in a variety of shapes, sizes, and designs for various situations. It is typically made of spring metal and has bevelled jaws that contact the tooth, and a bow that connects the jaws. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
622185718
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
D661R877C012FG1AlpenR877C012FG2019-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800075627704OSUNG MNDOSUNG MND Co., Ltd.EEF2025-11-03
00889813063606Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEEF2024-12-12
00889813063613Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEEF2024-11-30
00889813063620Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEEF2024-11-30
00889813063576Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEEF2024-10-01
00889813063590Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEEF2024-10-01
08800075603364OSUNG MNDOSUNG MND Co., Ltd.EEF2024-03-06
08800075603371OSUNG MNDOSUNG MND Co., Ltd.EEF2024-03-06
08800075603388OSUNG MNDOSUNG MND Co., Ltd.EEF2024-03-06
08800075603395OSUNG MNDOSUNG MND Co., Ltd.EEF2024-03-06
08800075603401OSUNG MNDOSUNG MND Co., Ltd.EEF2024-03-06
08800075621313OSUNG MNDOSUNG MND Co., Ltd.EEF2024-03-06
08800075603357OSUNG MNDOSUNG MND Co., Ltd.EEF2024-02-23
08800075603418OSUNG MNDOSUNG MND Co., Ltd.EEF2024-02-23
08800075603425OSUNG MNDOSUNG MND Co., Ltd.EEF2024-02-23
08800075603432OSUNG MNDOSUNG MND Co., Ltd.EEF2024-02-23
08800075621320OSUNG MNDOSUNG MND Co., Ltd.EEF2024-02-23
08800075626424OSUNG MNDOSUNG MND Co., Ltd.EEF2024-02-23
08964003163228NivoB. Ali ImpexEEF2024-01-27
08964003163235NivoB. Ali ImpexEEF2024-01-27
08964003163242NivoB. Ali ImpexEEF2024-01-27
08964003163259NivoB. Ali ImpexEEF2024-01-27
08964003163266NivoB. Ali ImpexEEF2024-01-27
08964003163204NivoB. Ali ImpexEEF2024-01-25
08964003163211NivoB. Ali ImpexEEF2024-01-25
10889950088200Rubber Dam ClampsHU-FRIEDY MFG. CO., LLCEEF2023-07-03
10889950088217Rubber Dam ClampsHU-FRIEDY MFG. CO., LLCEEF2023-07-03
10889950121754Rubber Dam ClampsHU-FRIEDY MFG. CO., LLCEEF2023-07-03
10889950121761Rubber Dam ClampsHU-FRIEDY MFG. CO., LLCEEF2023-07-03
10889950133986Rubber Dam ClampsHU-FRIEDY MFG. CO., LLCEEF2023-07-03