>> (FDA) FOOD AND DRUG ADMINISTRATION - K030266

Data: 09/01/02

KO30266
Trade/Device Name: Cem-OsteticTM
Regulatory Class: Unclassified
Product Code: MQV
Dated: January 2 1,2003
Received: January 27,200

>> BI-OSTETIC™ - BERKELEY ADVANCED BIOMATERIALS

Data: --/--/--

Bi-Ostetic™ is a mixture with a nominal composition of 60% hydroxyapatite and 40% ß-tri-calcium phosphate. These materials have been the topic of extensive clinical studies for a several decades

>> CEM-OSTETIC™ - BERKELEY ADVANCED BIOMATERIALS

Data: 09/01/02

Cem-Ostetic™ contains calcium based inorganic compounds, which have been the subject of extensive clinical studies for more than 30 years that demonstrated their excellent biocompatibility.