FDA.reportPublic FDA data

STOMA®

Primary DI
ESAM4954001
Brand
STOMA®
Company
Storz am Mark GmbH
Model
4954.00
Catalog number
4954.00
Device description
Mirrors, plain, s.4, doz.
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
EAXMIRROR, MOUTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAXMirror, MouthDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESAM4954000Direct MarkingHIBCC0
ESAM4954001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental mirror, reusableA hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. 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
ESAM1380200003041STOMA®138-020000-304138-020000-3042026-07-30
ESAM1380210003041STOMA®138-021000-304138-021000-3042026-07-30
ESAM1387030003041STOMA®138-703000-304138-703000-3042026-07-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G879MMFS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMFS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMFSCS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMFSCS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPSCS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPSCS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
00840456218341JMUJMU DENTAL, INCEAX2026-07-07
00840456218358JMUJMU DENTAL, INCEAX2026-07-07
00840456218365JMUJMU DENTAL, INCEAX2026-07-07
00840456218372JMUJMU DENTAL, INCEAX2026-07-07
00840456218389JMUJMU DENTAL, INCEAX2026-07-07
00840456218396JMUJMU DENTAL, INCEAX2026-07-07
08961104622579Dental Mouth Mirror MELPEX BEAUTY INSTRUMENTSEAX2026-05-21
08961104622586Dental Mouth MirrorMELPEX BEAUTY INSTRUMENTSEAX2026-05-21
08961104622944Dental Mouth MirrorMELPEX BEAUTY INSTRUMENTSEAX2026-05-21
G149TBSB3110TBS BASICSACME ENTERPRISE.EAX2026-05-16
G149TBSB3120TBS BASICSACME ENTERPRISE.EAX2026-05-16
G149TBSB3130TBS BASICSACME ENTERPRISE.EAX2026-05-16
G149TBSB3140TBS BASICSACME ENTERPRISE.EAX2026-05-16
1081000052669420/20™PARKELL, INC.EAX2025-09-26
M633680501B4JEDMEDJEDMED INSTRUMENT COMPANYEAX2023-02-03
10371347002550Mirror Front Surface Cone Socket #4The Atlanta Dental Supply CompanyEAX2022-11-23
10371347002567Mirror Front Surface Simple Stem #4The Atlanta Dental Supply CompanyEAX2022-11-23
10371347002574Mirror Front Surface Cone Socket #5The Atlanta Dental Supply CompanyEAX2022-11-23
10371347002581Mirror Front Surface Simple Stem #5The Atlanta Dental Supply CompanyEAX2022-11-23
10818207024203Vista RSS Mirror HandleVista DentalEAX2022-09-01
10818207024210Vista RCS Mirror HandleVista DentalEAX2022-09-01
10818207024227Vista OCS Mirror HandleVista DentalEAX2022-09-01