For EU (CE marking, MDD) & USA (510(k)):

 

​DISCLAIMER:

Indications of one device may vary in different markets due to regulatory differences in each market.

The contents below are in accordance with the CE marking of the medical device under EU Medical Devices Directive (MDD 93/42/EEC, as amended by Directive 2007/47/EC) and the US 510(k) Premarket Notification requirements.

The claims under this section of the website are not supported for Korean MFDS permission purposes.

 

Product Description

OCS-B Collagen^® is a combination of purified cancellous bovine bone mineral granules (OCS-B^®) and 10% porcine collagen in block form in a blister pack, or in a cylindrical form in a syringe and a blister pack. It is sterilized by -irradiation.

 

Indications

OCS-B Collagen^® is recommended for:

- Augmentation or reconstructive treatment of the alveolar ridge.

- Filling of intrabony periodontal defects.

- Filling of defects after root resection, apicoectomy, and cystectomy.

- Filling of extraction sockets to enhance preservation of the alveolar ridge.

- Elevation of the maxillary sinus floor.

- Filling of periodontal defects in conjunction with products intend for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).

- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

 

 

 

 

For Korea (MFDS permission):

DISCLAIMER:

Indications of one device may vary in different markets due to regulatory differences in each market.

The contents below are in accordance with the medical device permission from the Korean Ministry of Food and Drug Safety.

In addition, the claims below have been deliberated by the Medical Device Advertisement Pre-deliberation Committee of the Korea Medical Devices Industry Association.

The claims under this section of the website are not supported for EU CE marking or US 510(k) purposes.

 

“This product is a 'medical device'. Please carefully read 'Precautions' and ‘Instruction' before use.”

 

OCS-B Collagen^® consists of cancellous bone granules of OCS-B^® and purified type I collagen derived from porcine skin.

 

Indications

Bone filling in extraction socket

Guided bone regeneration

Guided tissue regeneration

Features

It can be transformed into various shapes in dry condition or when wetted with blood or saline.

Collagen is an extracellular matrix component of bone tissue that creates a favorable environment for bone regeneration and decomposes after a certain time.

Good new bone formation and space maintenance.

Accelerates bone regeneration, which helps with aesthetic problems in soft tissue.

 

 

 

 

 

 

 

 

Deliberation No.: 2015-I10-13-0873