Bl-Osc-H

FDA UDIEUDAMED

Class II (US FDA UDI)

by Z-Systems AG

Identity

Trade Name: BL-OSC-H FDA UDI
Generic Name: Dental prosthesis/implant abutment screw FDA UDI
Device Name: Ceramic Basal Screw, incl. single-use screwdriver FDA UDI
Model / Reference: BL-OSC-H FDA UDI
Description: Ceramic Basal Screw, incl. single-use screwdriver FDA UDI

Identifiers

Catalog Number: BL-OSC-H FDA UDI
Primary DI / UDI-DI: 07640166760870 FDA UDI
510(k) Number: K190243 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Dental prosthesis/implant abutment screw FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental prosthesis/implant abutment screw

Bl-Osc-H by Z-Systems AG — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental prosthesis/implant abutment screw.

Azure — TERRATS MEDICAL SL. · Class II
Inclusive — PRISMATIK DENTALCRAFT, INC. · Class II
KLOCKNER — SOADCO, S.L. · Class II
DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class II
Implant Prosthetics — PREAT Corporation · Class II
INNO Submerged Implant System-Cemented Abutment — Cowellmedi Co., Ltd · Class II
MEDENTiKA — Medentika GmbH · Class II
Azure — TERRATS MEDICAL SL. · Class II

Cleared under the same submission

K190243 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Z-Systems AG

Sources (2)

FDA UDI 2bf686f4-c1bd-4c9c-a24d-02f841991a32 36 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 19, 2026