FDA.reportPublic FDA data

Hygenic

Primary DI
D661H070830
Brand
Hygenic
Company
COLTENE/WHALEDENT INC
Model
H07083
Device description
"Metal Frame - 6"""
Published
2019-02-12
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
EJEFrame, Rubber Dam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJEFrame, Rubber DamDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D661H070830PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam frameA flexible border that holds a rubber dam in a stretched state to improve access to the field of operation. It is typically made of a thick stainless steel U-shaped rod that has small hook-like retainers attached at intervals along its length. This is a reusable device.

Regulatory Flags#

DUNS number
622185718
Device count
1
Premarket exempt
true
Lot or batch
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
G149TBSB2100TBS BASICSACME ENTERPRISE.EJE2026-05-16
00813677023339PDT, Inc.PDT, INC.EJE2024-06-27
00813677024985PDT, Inc.PDT, INC.EJE2024-06-27
D2483553190Plast FrameHAGER WORLDWIDE, INC.EJE2024-04-16
08800075603463OSUNG MNDOSUNG MND Co., Ltd.EJE2024-02-23
08800075603470OSUNG MNDOSUNG MND Co., Ltd.EJE2024-02-23
07506338321761Nic Tone, MDC Dental MDC DENTALEJE2023-11-17
00014081053190Plast FrameHAGER WORLDWIDE, INC.EJE2023-03-27
07630392900409HysolateDent4You AGEJE2023-02-28
07630392900416HysolateDent4You AGEJE2023-02-28
07630392900423HysolateDent4You AGEJE2023-02-28
07630392900430HysolateDent4You AGEJE2023-02-28
07630392900447HysolateDent4You AGEJE2023-02-28
07506338300575Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300667Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300674Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300681Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300698Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300704Nic Tone, MDC Dental MDC DENTALEJE2022-12-17
07506338300568Nic Tone, MDC DentalMDC DENTALEJE2022-12-08
07506338300599Nic Tone, MDC Dental MDC DENTALEJE2022-12-08
D24835531919Plast FrameHAGER WORLDWIDE, INC.EJE2022-12-05
07506338300582Nic Tone, MDC DentalMDC DENTALEJE2022-11-04
07506338300636Nic Tone, MDC Dental MDC DENTALEJE2022-11-03
00302731714011YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
00302731770017YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
00302731771014YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
00302731776019YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
00302731777016YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16
10302731714018YoungYOUNG DENTAL MANUFACTURING I, LLCEJE2022-10-16