Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014211822

FEI Number

3014298539

Entity Name

Berkeley Advanced Biomaterials

City/State/Country

Berkeley, CA, US

Establishment Address

2800 Seventh Street, Berkeley, CA 94710, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Berkeley Advanced Biomaterials (Owner Number: 9049267)

Owner / Operator Contact Address

2800 Seventh Street, --, Berkeley, CA 94710, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K022622

PMA Number

N/A

All Registered Proprietary Names

B-GENIN and R-GENIN Cem-Ostetic Putty Injection Kit Bi-O Plus Bi-Ostetic GenerOs Foam, Tri-Ostetic Foam Bi-Ostetic Foam, Cem-Ostetic Foam Cem-Ostetic Bone;CemO-10G,CemO-20G Bi-Ostetic Bioactive Glass Foam OsteoMatrix Bi-Ostetic Foam and Putty NexGraft EvoGraft OptiFuse Cem-Ostetic, CemO-20P,CemO-05P

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2010-10-07
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2010-10-07
GXP	Methyl Methacrylate For Cranioplasty	Neurology	Class 2	882.5300	2007-12-07
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2007-12-07
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2007-12-07
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2007-12-07
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2007-12-07
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2007-12-07
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2017-11-14
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2010-10-07
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2007-12-05

Official Correspondent

Mesfin Mengesha

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Berkeley Advanced Biomaterials

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30
K173933	Xenco Medical, LLC	Sorrento Bioglass Bone Graft Substitute	2018-09-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014211822. Last updated year: 2026. Please use registration number 3014211822 when referencing this establishment in official correspondence.