Kerecis Gingiva Graft
by Kerecis Limited Iceland 510(k)
510(k) K192612
Product code NPL
Overview
The Kerecis Gingiva Graft is a barrier device of animal origin designed for intraoral use. Classified as a Class II medical device under FDA regulations, it is intended to support soft tissue regeneration and wound healing in gingival applications. Its composition is derived from fish skin, providing a natural scaffold to promote tissue integration and stability in periodontal procedures.
This device is supplied as a single-use, sterile barrier graft intended for intraoral dental applications. It is regulated under FDA 510(k) clearance (K192612) and falls under the product code NPL (Barrier, Animal Source, Intraoral). No MRI safety information is specified, and it is not intended for reusable applications. Storage and handling must adhere to sterile medical device protocols to ensure integrity prior to use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192612 | Date13 Nov 2020 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NPL
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3930
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
Kerecis fish-skin products are FDA-cleared for multiple clinical applications, including partial and full-thickness wounds, trauma wounds, and surgical wounds. Our grafts can be expanded to cover larger wounds with less fish-skin material, creating cost efficiencies and reducing waste.
Other devices from Kerecis Limited
Questions
What is the Kerecis Gingiva Graft used for in dental procedures?
The Kerecis Gingiva Graft is designed as a barrier device made from fish skin to support soft tissue regeneration and wound healing specifically in gingival applications. It acts as a natural scaffold to promote tissue integration and stability during periodontal procedures, helping to guide and protect healing in the gum area.
Is the Kerecis Gingiva Graft intended for reuse, or is it single-use only?
The Kerecis Gingiva Graft is explicitly labeled as a single-use device. It is supplied sterile and must be discarded after one use to maintain sterility and ensure patient safety, as reuse is not permitted or supported by its design.
How should the Kerecis Gingiva Graft be stored to preserve its integrity before use?
Since the Kerecis Gingiva Graft is a sterile medical device, it must be stored and handled according to standard sterile medical device protocols. This includes keeping it in its original packaging, protecting it from contamination, and ensuring it remains dry and free from physical damage until ready for use.
What regulatory pathway was followed for FDA clearance of the Kerecis Gingiva Graft?
The Kerecis Gingiva Graft received FDA clearance through a 510(k) submission, classified as a Traditional clearance under the Dental advisory committee (DE). It was determined to be Substantially Equivalent to a predicate device and falls under the product code NPL (Barrier, Animal Source, Intraoral). The clearance number is K192612, and the decision was finalized on November 13, 2020.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K192612