FDA.reportPublic FDA data

STOMA®

Primary DI
ESAM14445001
Brand
STOMA®
Company
Storz am Mark GmbH
Model
14445.00
Catalog number
14445.00
Device description
Gingiva graft packing instrument, 2mm/2mm
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
EMJELEVATOR, SURGICAL, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESAM14445000Direct MarkingHIBCC0
ESAM14445001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental material application tool, reusableA hand-held manual dental instrument intended to be used for the application of a dental material (e.g., composite resin) to a dental prosthesis or to a patient’s tooth/teeth; the material is not included. It includes a handle with an application tip which holds the material on its surface; it is not a syringe- or pistol-like device. 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

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Primary DI, Brand, Company table
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G879LXB50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-25
G879103420TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G8791034210DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G8791034220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G879106049TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G8791061050DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G8791061170DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G879101067S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101067L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101067M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101068L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101068M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101068S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
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00850083275549Intrace USAPILOTIS TECH LLCEMJ2026-07-03
00810189451216Surgical DesignSurgical Design, Inc.EMJ2026-06-06
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00810189451230Surgical DesignSurgical Design, Inc.EMJ2026-06-06
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00810189451261Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451278Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451285Surgical DesignSurgical Design, Inc.EMJ2026-06-06