FDA.report

STOMA®

Primary DI
ESAM13388050
Brand
STOMA®
Company
Storz am Mark GmbH
Model
13388.05
Catalog number
13388.05
Device description
Tissue punch, Palti, Ø 5mm
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

Related Records

Contact Domains

Product Codes

CodeName
EJLBUR, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ESAM13388050Direct MarkingHIBCC0
ESAM13388051PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental soft-tissue coring punch, reusableA dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. Sometimes referred to as a mucotome, it will typically be designed with a handle at the proximal end for manual operation or for mounting into a dental power tool (e.g., contra-angle low-speed drill handpiece), and have a cylindrical hollow tube-like head with a sharp cutting at the distal end. It is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 DIBrandModelCatalogPublished
ESAM1000STOMA®1.00 1.00 2025-04-30
ESAM13309100STOMA®13309.1013309.102025-04-30
ESAM14060470STOMA®14060.4714060.472025-04-30
ESAM14061470STOMA®14061.4714061.472025-04-30
ESAM14065470STOMA®14065.4714065.472025-04-30
ESAM14089470STOMA®14089.4714089.472025-04-30
ESAM14094470STOMA®14094.4714094.472025-04-30
ESAM14446250STOMA®14446.2514446.252025-04-30
ESAM14621760STOMA®14621.7614621.762025-04-30
ESAM14762480STOMA®14762.4814762.482025-04-30
ESAM23053120STOMA®23053.1223053.122025-04-30
ESAM23080000STOMA®23080.0023080.002025-04-30
ESAM23080131STOMA®23080.1323080.132025-04-30
ESAM23080160STOMA®23080.1623080.162025-04-30
ESAM3840130STOMA®3840.133840.132025-04-30
ESAM3841130STOMA®3841.133841.132025-04-30
ESAM4028010STOMA®4028.014028.012025-04-30
ESAM6550400STOMA®6550.406550.402025-04-30
ESAM6551100STOMA®6551.106551.102025-04-30
ESAM14140470STOMA®14140.4714140.472025-04-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810126508270Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508294Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508300Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508317Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508324Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
07908738731940DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730585DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730592DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730608DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730615DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730622DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730639DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730646DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730653DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730660DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730677DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730684DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730691DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730707DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730714DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730721DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730738DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730745DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730752DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730769DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730776DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730783DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730790DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730806DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730813DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10