FDA.reportPublic FDA data

STOMA®

Primary DI
ESAM12920001
Brand
STOMA®
Company
Storz am Mark GmbH
Model
12920.00
Catalog number
12920.00
Device description
Perio probe, CQ-2N Nabers, colourcoded, Ø 6mm, DE
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
EIXPROBE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIXProbe, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESAM12920000Direct MarkingHIBCC0
ESAM12920001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal probe, reusableA hand-held dental instrument intended to be inserted into a periodontal pocket around a tooth to measure the depth of the periodontal pocket, in order to assess the health of the periodontium and to monitor the progress of disease. It is typically made of high-grade stainless steel and has a distal end with a thin, angled or curved blunt tip with scaled markings to indicate measurements (typically millimetres). 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
G8791021510DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791021511B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102151H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102157H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102158H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102159H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G87910217U150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791021NH0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G87910223C1150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G87910223GF0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791022NH0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791023AU150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791026QW0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CP02H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CP110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CP1150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102GFP0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102W11B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102WGF0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
B382SD19300Surgical DirectSurgical Direct, Inc.EIX2026-07-31
08057639712677Needle tip - BLKMC BIO SRLEIX2026-07-28
08057639712684Needle tipMC BIO SRLEIX2026-07-28
00850083275693Intrace USAPILOTIS TECH LLCEIX2026-07-03
10856364008100Florida ProbeFlorida Probe CorporationEIX2023-08-08
07898506811861QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811878QuinelatoSchobell Industrial LtdaEIX2022-12-08