STOMA® micro-screw

FDA UDI

Class II (US FDA UDI)

by Storz am Mark GmbH

Identity

Trade Name: STOMA® micro-screw FDA UDI
Generic Name: Craniofacial bone screw, non-bioabsorbable FDA UDI
Device Name: STOMA® micro-screws Ø1,2 X 8mm are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures in the dental field. They are recommended especially for the fixation of transplanted bone blocks and small grafts during the augmentation process in the oral cavity and maxillomandibular surgical field, e.g. for horizontal, vertical or 3D augmentative grafts. The small-sized diameter of the screw head enables various applications. STOMA® micro-screws are delivered in non-sterile conditions. FDA UDI
Model / Reference: 23061.08 FDA UDI
Description: STOMA® micro-screws Ø1,2 X 8mm are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures in the dental field. They are recommended especially for the fixation of transplanted bone blocks and small grafts during the augmentation process in the oral cavity and maxillomandibular surgical field, e.g. for horizontal, vertical or 3D augmentative grafts. The small-sized diameter of the screw head enables various applications. STOMA® micro-screws are delivered in non-sterile conditions. FDA UDI

Identifiers

Catalog Number: 23061.08 FDA UDI
Primary DI / UDI-DI: ESAM23061081 FDA UDI
510(k) Number: K080430 FDA UDI
FDA Product Code: DZL FDA UDI
GMDN Term: Craniofacial bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4880 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 8 Millimeter FDA UDI
Outer Diameter — 1.2 Millimeter FDA UDI

Category: Craniofacial bone screw, non-bioabsorbable

STOMA® micro-screw by Storz am Mark GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Storz am Mark GmbH

Sources (1)

FDA UDI 86dd83c5-4076-4c77-9777-20f703468655 37 fields · synced May 30, 2026