FDA.reportPublic FDA data

STOMA®

Primary DI
ESAM3460601
Brand
STOMA®
Company
Storz am Mark GmbH
Model
3460.60
Catalog number
3460.60
Device description
Rubber dam clamp, fig.60
Published
2020-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
ESAM3460600Direct MarkingHIBCC0
ESAM3460601PrimaryHIBCC0

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
+49746592600sam@stoma.de

Regulatory Flags#

DUNS number
318268125
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
ESAM14447011STOMA®14447.0114447.012026-05-26
ESAM14447021STOMA®14447.0214447.022026-05-26
ESAM14447031STOMA®14447.0314447.032026-05-26
ESAM14447041STOMA®14447.0414447.042026-05-26
ESAM3851141STOMA®3851.143851.142026-03-25
ESAM23040001STOMA®23040.0023040.002025-10-23
ESAM23049301STOMA®23049.3023049.302025-10-23
ESAM3387101STOMA®3387.103387.102020-08-27
ESAM12919001STOMA®12919.0012919.002020-08-27
ESAM12922001STOMA®12922.0012922.002020-08-27
ESAM12924001STOMA®12924.0012924.002020-08-27
ESAM12926001STOMA®12926.0012926.002020-08-27
ESAM12927001STOMA®12927.0012927.002020-08-27
ESAM12930001STOMA®12930.0012930.002020-08-27
ESAM12931001STOMA®12931.0012931.002020-08-27
ESAM23053141STOMA®23053.1423053.142023-06-19
ESAM2919101STOMA®2919.102919.102020-08-27
ESAM2922101STOMA®2922.102922.102020-08-27
ESAM2923101STOMA®2923.102923.102020-08-27
ESAM23051061STOMA® titanium bone screw23051.0623051.062015-10-16

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