Regenomer - Absorbable Collagen Matrix
Regenomer is Sponge-like absorbable and porous collagen matrix). Made from purified type I atelocollagen derived from porcine skin sources in South Korea). Physically crosslinked). Biocompatible). Recommended resorption time is 4 weeks).
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Product Details
Indications
- Bone filling augmentation for use in filling of extraction sockets.6)
- To stop bleeding after an odontectomy.6)
- To cover the surface of a wound created by an odontectomy.6)
- Wound dressing for dental surgery.6)
The three types of Regenomer® (syringe, plug, and block) are the same material intended to be used the same way but only in different shapes to meet clinicians' preference in shaping and modification according to defect sites.
References
- Physical and Chemical Test of Regenomer (Bench Test), NIBEC Co., Ltd., data on file.
- Raw Materials (Regenomer), NIBEC Co., Ltd., data on file.
- Manufacturing (Regenomer), NIBEC Co., Ltd., data on file.
- Biocompatibility Test, NIBEC Co., Ltd., data on file.
- Performance Test - Animal, NIBEC Co., Ltd., data on file.
- Clinical Evaluation Report (Regenomer), NIBEC Co., Ltd., data on file.
For 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 US 510(k) Premarket Notification requirements.
- The claims under this section of the website are not supported for EU CE marking or Korean MFDS permission purposes.
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