FDA.reportPublic FDA data

Dam Frame

Primary DI
D701RDF2
Brand
Dam Frame
Company
PULPDENT CORPORATION
Model
RDF
Device description
Radiolucent Rubber Dam Frame
Published
2021-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
D701RDF2PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method
High-level Disinfectant

Regulatory Flags#

DUNS number
001006089
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D701DEN2DENTIN CONDITIONING GELDEN2016-07-21
D701EA2ETCH-ALL™ EA2016-09-01
D701EA52ETCH-ALL™ Dental Etching Gel EA52016-07-28
D701ER2ETCH ROYALE™ DENTAL ETCHING GELER2016-08-11
D701ER242ETCH ROYALE™ DENTAL ETCHING GEL ER242016-08-11
D701ER502ETCH ROYALE™ DENTAL ETCHING GELER502016-08-11
D701ER50R2Etch RoyaleER50R2016-09-01
D701ER62ETCH ROYALE™ DENTAL ETCHING GEL ER62016-08-11
D701ET122ETCH-RITE™ DENTAL ETCHING GEL ET122016-07-28
D701ET12G2ETCH-RITE™ DENTAL ETCHING GEL ET12G2016-07-28
D701ET182ETCHANTET182016-09-01
D701ET242ETCH-RITE™ DENTAL ETCHING GEL ET242016-08-11
D701ET502ETCH-RITE™ DENTAL ETCHING GEL ET502016-08-11
D701ET50R2ETCH-RITE™ DENTAL ETCHING GELET50R2016-08-11
D701ET62ETCH-RITE™ DENTAL ETCHING GELET62016-07-28
D701ETCH2ETCH-RITE™ DENTAL ETCHING GELETCH2016-07-28
D701ETTWIN2ETCH-RITE™ DENTAL ETCHING GEL ETTWIN2016-07-28
D701SER2ETCH ROYALE SAMPLESER2018-08-10
D701SETCH2ETCH RITE SAMPLESETCH2018-08-10
D701ET1442ETCH-RITE™ DENTAL ETCHING GEL ET1442016-08-11

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