Bl-Ost-H

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref BL-OST

by Z-Systems AG

Identity

Trade Name: BL-OST-H FDA UDI
BL-OST FDA UDI
Generic Name: Dental prosthesis/implant abutment screw FDA UDI
Device Name: BL-OST EUDAMED
Titanium basal screw, including single-use screwdriver FDA UDI
Basal Screw FDA UDI
Model / Reference: BL-OST EUDAMEDFDA UDI
BL-OST-H FDA UDI
Description: Titanium basal screw, including single-use screwdriver FDA UDI
Basal Screw FDA UDI

Identifiers

Catalog Number: BL-OST-H FDA UDI
BL-OST FDA UDI
Primary DI / UDI-DI: 07640166760863 EUDAMEDFDA UDI
07640166764700 FDA UDI
Basic UDI-DI: B-07640166760863 EUDAMED
510(k) Number: K190243 FDA UDI
FDA Product Code: DZE FDA UDI
NHA FDA UDI
EMDN Code: P01020101 DENTAL IMPLANTS EUDAMED
GMDN Term: Dental prosthesis/implant abutment screw FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 872.3640 FDA UDI
872.3630 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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-Ost-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 (3)

FDA UDI 435c50a9-2e46-41be-b732-2e73d4a131c4 36 fields · synced Jun 20, 2026
FDA UDI 4786bbee-0811-4ffc-ba66-459c19849185 36 fields · synced May 30, 2026
EUDAMED 926fd626-8595-4ac7-ab78-f635e5a90cc2 61 fields · synced Jun 20, 2026