FDA.reportPublic FDA data

STOMA®

Primary DI
ESAM13318000
Brand
STOMA®
Company
Storz am Mark GmbH
Model
13318.00
Catalog number
13318.00
Device description
Depth measuring instrument, graduated
Published
2020-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMLCHISEL, BONE, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMLChisel, Bone, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESAM13318000Direct MarkingHIBCC0
ESAM13318001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implantation depth/angle gauge, reusableA device designed to be used during the planning and post-osteotomy stages of a dental implantation procedure, prior to surgical implant placement/fixation, to measure/determine various lengths (e.g., drill depth of the osteotomy cavity, mucosal height, distance between implants/teeth for determining the mesiodistal position of the implant) and/or angles [e.g., direction of the perforation in relation to the antagonist arch], typically to help select an appropriate final prosthetic abutment to be installed. It is typically graduated and may be a hand-held instrument or a stand-alone device placed intraorally; some types are intended for use during x-ray imaging. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
false
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
00348783012316Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEML2026-04-02
00840018672505Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018672666Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018672970Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018674189Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-11
00840018667396Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-10
00840018665682Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-09
00840018666030Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-09
00840018663732Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-04
00840018665491Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-04
00840018665507Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-02-04
00840018661202Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661219Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661226Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661233Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00840018661240Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEML2026-01-28
00194613013448MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-08-01
00194613013479MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-08-01
00194613013486MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-08-01
D92820001580BAUER GUARDED OSTEO 8MM STRW.H. Holden, Inc.EML2025-05-21
00194613013462MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-03-21
00194613104290MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-03-21
00194613108601MSI Precision Specialty InstrumentsMed Saver, Inc.EML2025-03-21
00888912126991DJO SURGICALEncore Medical, L.P.EML2024-08-22
00888912127028DJO SURGICALEncore Medical, L.P.EML2024-08-22
00887482050606Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.EML2024-08-12
00813677023254PDT, Inc.PDT, INC.EML2024-07-01
00813677023261PDT, Inc.PDT, INC.EML2024-07-01
00888912088725DJO SURGICALDJO, LLCEML2024-05-20
00842517105652Karl SchumacherKarl Schumacher Dental, LLCEML2024-05-06