For EU (CE marking):

 

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).

The claims under this section of the website are not supported for US 510(k) or Korean MFDS permission purposes.

 

Regenomer^® is:

- Sponge-like absorbable and porous collagen matrix.¹⁾

- Made from purified type I atelocollagen derived from porcine skin sources in South Korea.²⁾

- Physically crosslinked.³⁾

- Biocompatible.⁴⁾

- Recommended resorption time is 4 weeks.⁵⁾

 

Indications

1. Bone filling augmentation for use in filling of extraction sockets.⁶⁾

2. To stop bleeding after an odontectomy.⁶⁾

3. To cover the surface of a wound created by an odontectomy.⁶⁾

4. 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

1) Physical and Chemical Test of Regenomer (Bench Test), NIBEC Co., Ltd., data on file.

2) Raw Materials (Regenomer), NIBEC Co., Ltd., data on file.

3) Manufacturing (Regenomer), NIBEC Co., Ltd., data on file.

4) Biocompatibility Test, NIBEC Co., Ltd., data on file.

5) Performance Test - Animal, NIBEC Co., Ltd., data on file.

6) 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.

 

The Regenomer^® is in general recommended for the filling of extraction sockets and periodontal defect. The indication for use depending on the device format is further classified as described in following table.

Format	Syringe	Plug	Block
Indication for use	- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR)   - Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)	- Filling of extraction sockets   - Augmentation or reconstructive treatment of the alveolar ridge   - Elevation of maxillary sinus floor	- Augmentation or reconstructive treatment of the alveolar ridge   - Elevation of maxillary sinus floor

 

 

 

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.”

 

Regenomer is a sponge-type periodontal tissue regeneration graft composed of collagen. Filling the periodontal tissue defect site with collagen, a major protein constituting bone tissue, secures a space for the surrounding osteoblasts to grow and creates a favorable environment for bone regeneration. Osteoblasts can also be used in combination.

 

Preventing penetration of food and other foreign substances into extraction socket

Wound protection

Acceleration of new tissue growth

Prevention of soft tissue retraction in the extraction socket (gingival recession prevention)

Prevention of alveolar bone absorption

 

 

 

 

 

Deliberation No.: 2015-I10-13-0877

 

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