UNICARE BIOMEDICAL INC.

Address:23011 Moulton Pkwy Ste J11,Laguna Hills,CA,92653,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Bone Grafting Material, Synthetic (LYC) (1)

Premarket Exempt

Clear

Unigraft - D767U0302051 Catalog Number : U03-0205

Device Description : Unigraft is made of synthetic bioactive glass material. The product is convenien Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in a sterile vial and stored within a hermetically sealed foil pouch to ensure product sterility prior to implantation. Unigraft offers an osteogenic framework for new bone growth and bolsters a higher level of osteoblastic activity to enhance bone regeneration. FDA has cleared this product for use in treating periodontal defects, extractions sites, sinus elevation, apicoectomy and root resection, cranial and facial augmentation and augmentation of the alveolar ridges.

Device Class :

Duns Number: 038023573

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 5

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