Bone Level Fixture

FDA UDI

Class II (US FDA UDI)

by Inosys, Inc.

Identity

Trade Name: Bone Level Fixture FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Device Name: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø4.6 X 7.5mm FDA UDI
Model / Reference: PBF 4507S FDA UDI
Description: Biotem NON-MICRO THREAD TYPE AR FIXTURE(SLA) Ø4.6 X 7.5mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00810112920123 FDA UDI
510(k) Number: K190641 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Screw endosteal dental implant, two-piece 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Category: Screw endosteal dental implant, two-piece

Bone Level Fixture by Inosys, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Screw endosteal dental implant, two-piece.

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LW Vis Abutment — Ossvis Co., Ltd. · Class II
s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD · Class II
ET II Fixture SA Mini No-Mounted — HIOSSEN INC. · Class II
LW Vis Abutment — Ossvis Co., Ltd. · Class II
PRAMA RF WHITE IMPLANT ZIRTI — SWEDEN & MARTINA INC · Class II

Cleared under the same submission

K190641 also covers:

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: Inosys, Inc.

Sources (1)

FDA UDI 229dcff9-4225-45fa-a965-857f213a2db5 34 fields · synced May 30, 2026