FDA.reportPublic FDA data

STOMA®

Primary DI
ESAM5171021
Brand
STOMA®
Company
Storz am Mark GmbH
Model
5171.02
Catalog number
5171.02
Device description
margin fit - impression tray, uj, XS U2A
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
EHYTRAY, IMPRESSION, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESAM5171020Direct MarkingHIBCC0
ESAM5171021PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression tray, reusableA horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). 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

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Primary DI, Brand, Company table
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D12518N4032Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518N4042Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518N4052Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
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D12518S4022Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518S4032Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D12518T4012Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
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D12518T4032Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254334Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254344Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254354Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254364Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254374Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
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D1254394Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254404Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254514Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254524Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254534Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254544Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254554Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
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D1254584Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254594Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D1254604Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09
D125N4012Premium PlusPremium Plus (Dongguan) LimitedEHY2026-06-09