BioResorb® Macro Pore

FDA UDI

Class II (US FDA UDI)

by Biovision GmbH Entwicklung, Herstellung und Vertrieb von Biomaterialien

Identity

Trade Name: BioResorb® Macro Pore FDA UDI
Generic Name: Synthetic bone graft FDA UDI
Device Name: 1400-3200 µm; 1 x 2.0 ml FDA UDI
Model / Reference: KE 19014120 FDA UDI
Description: 1400-3200 µm; 1 x 2.0 ml FDA UDI

Identifiers

Catalog Number: KE 19014120 FDA UDI
Primary DI / UDI-DI: 04260310344157 FDA UDI
510(k) Number: K050260 FDA UDI
FDA Product Code: LYC FDA UDI
GMDN Term: Synthetic bone graft FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3930 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

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

FDA UDI

Category: Synthetic bone graft

For dental practitioners and surgeons, BioResorb Macro Pore is a cutting-edge bone grafting material used for structural bone replacement. Made from porous ceramic materials or harvested sea coral, this single-use device provides a framework for bone growth with exceptional stability and durability.

Similar devices

Also classified as Synthetic bone graft.

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Bicera® Resorbable Bone Substitute — Wiltrom Co., Ltd. (Chutung) · Class II
OsseoSculpt Moldable ABG, 3cc — Biogennix, LLC · Class II
Montage Settable Bone Putty — ABYRX, INC. · Class II
IngeniOS HA — curasan AG · Class II
Osbone Dental — curasan AG · Class II
Bicera® Resorbable Bone Substitute — WILTROM INC. · Class II

Cleared under the same submission

K050260 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: Biovision GmbH Entwicklung, Herstellung und Vertrieb von Biomaterialien

Sources (1)

FDA UDI 1720a2f2-8d8b-456f-8aca-98884ca9ffef 35 fields · synced Jul 10, 2026