Regenomer

FDA UDI

Class II (US FDA UDI)

by Nibec Co., Ltd.

Identity

Trade Name: Regenomer FDA UDI
Generic Name: Dental bone matrix implant, animal-derived FDA UDI
Device Name: Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only. FDA UDI
Model / Reference: RSB2-L FDA UDI
Description: Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is manufactured in three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenomer® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809186549431 FDA UDI
510(k) Number: K150079 FDA UDI
FDA Product Code: NPM FDA UDI
GMDN Term: Dental bone matrix implant, animal-derived 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

Yes

FDA UDI

Category: Dental bone matrix implant, animal-derived

Regenomer by Nibec Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental bone matrix implant, animal-derived.

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Cleared under the same submission

K150079 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: Nibec Co., Ltd.

Sources (1)

FDA UDI 6eaae607-7b58-47ff-ab01-b460559b246e 37 fields · synced May 31, 2026