FDA.reportPublic FDA data

Power Dental U.S.A., Inc.

Primary DI
D943N7237
Brand
Power Dental U.S.A., Inc.
Company
Power Dental U.S.A. Inc.
Model
N7237
Catalog number
N7237
Device description
RUBBER DAM PLIER BREWER 17.5cm
Published
2021-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
D943N7237PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+1(815)363-8003info@mydentalusa.com

Regulatory Flags#

DUNS number
081305064
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D94320240Power Dental USA202420242021-06-20
D94341260Power Dental USA412641262021-06-20
D943ORCAA0Power Dental USAORCAAORCAA2021-06-20
D94367350Power Dental USA673567352021-06-20
D94367380Power Dental USA673867382021-06-20
D94367390Power Dental USA673967392021-06-20
D94367410Power Dental USA674167412021-06-20
D94367430Power Dental USA674367432021-06-20
D94367140Power Dental USA671467142021-06-20
D94367420Power Dental USA674267422021-06-20
D9436710E0Power Dental USA6710E6710E2021-07-13
D94367310Power Dental USA673167312021-06-20
D94367320Power Dental USA673267322021-06-20
D94367150Power Dental USA671567152021-06-20
D9436716Power Dental USA671667162021-06-20
D9436733Power Dental USA673367332021-06-20
D9436734Power Dental USA673467342021-06-20
D9436740Power Dental USA674067402021-06-20
D9436750Power Dental USA675067502022-01-08
D9431007E0Power Dental USA1007E1007E2021-07-13

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