Osung MND

A small container designed as a bone-harvesting device (bone trap) to collect autologous bone fragments, e.g., when drilling in the jawbone during a dental implant surgical procedure. It…

Registry build 21.09.26

A small container designed as a bone-harvesting device (bone trap) to collect autologous bone fragments, e.g., when drilling in the jawbone during a dental implant surgical procedure. It functions as a filter that traps the bone particles and is typically placed in a suction tube line between the site of operation and the suction unit. The harvested bone particles may be saved for future use. This is a single-use device.

2manufacturers in China registered for this device type
6catalogue numbers in this listing

Who Else Makes It

All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MXP
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51

Record

Regulatory record for Osung MND
Listed by Osung MND Co., Ltd., South Korea
FDA product code MXP
Device type Bone Particle Collector
Device class Class 1
Regulation 21 CFR 874.4800
Establishment Manufacturer
Premarket notification Exempt
Record published 2024-02-26
Record revised 2025-11-03 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date, serial number
Distribution end date 2025-10-31

Catalogue Numbers

Catalogue numbers for Osung MND
Catalogue number Size Status
STSBC-1 In distribution
ST1-F In distribution
BSF In distribution
BSF-5P In distribution
ST1 In distribution
BSF Withdrawn

Same Product Code

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Product Sold by Catalogue numbers
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PDT, Inc. PDT, Inc. 1
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Showing 12 of 23. All products under Bone Particle Collector

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer