Kerecis Gingiva Graft
FDA 510(k) K192612 · Kerecis Limited
510(k) numberK192612
Submission
- Device name
- Kerecis Gingiva Graft
- Applicant
- Kerecis Limited
Isafjordur, IS - Received
- September 20, 2019
- Decision date
- November 13, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NPL – Barrier, Animal Source, Intraoral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3930
- Specialty
- Dental
- Implant
- Yes
An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.
Other 510(k)s with product code NPL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242817 | Jason membraneNPL · Traditional | Botiss Biomaterials GmbH | 12/12/2025SE |
| K250512 | Augmented Gingival MatrixNPL · Traditional | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | 12/05/2025SE |
| K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®NPL · Traditional | Geistlich Pharma AG | 11/25/2025SE |
| K251062 | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich…NPL · Traditional | Geistlich Pharma AG | 08/14/2025SE |
| K250833 | SwissMembrane X; SwissMembrane X SocketNPL · Special | Geistlich Pharma AG | 04/15/2025SE |
| K233203 | Soft Tissue Augmentation Resorbable MatrixNPL · Traditional | Collagen Matrix, Inc. | 05/01/2024SE |
| K231513 | Oral MatrixNPL · Traditional | Beijing Biosis Healing Biolog Ical Technology… | 02/16/2024SE |
| K231305 | Endoform Dental MembraneNPL · Traditional | Aroa Biosurgery , Ltd. | 01/23/2024SE |
| K230091 | THE CoverNPL · Traditional | Purgo Biologics, Inc. | 10/06/2023SE |
| K223912 | InterCollagen® GuideNPL · Traditional | Sigmagraft, Inc. | 08/17/2023SE |
More from Sigmagraft, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251845 | Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKGN · Special | 07/16/2025SE |
| K251844 | Kerecis SurgiBind (50241)OXH · Special | 07/15/2025SE |
| K243843 | Tendon Protect (50242)OWY · Traditional | 06/04/2025SE |
| K241080 | Kerecis Parvus (50207)KGN · Traditional | 08/21/2024SE |
| K213904 | Kerecis OralNPL · Traditional | 09/30/2022SE |
| K213231 | Kerecis SiliconeKGN · Traditional | 06/29/2022SE |
| K202430 | Kerecis ReconstructOXH · Traditional | 05/02/2021SE |
| K190528 | MariGen Wound ExtraKGN · Traditional | 07/10/2019SE |
| K153364 | Kerecis SecureMeshOXE · Traditional | 08/19/2016SE |
| K132343 | Marigen Wound DressingKGN · Traditional | 10/23/2013SE |
Questions and answers
When was Kerecis Gingiva Graft cleared by the FDA?
Kerecis Gingiva Graft (K192612) received a 510(k) decision of Substantially Equivalent on November 13, 2020, 420 days after the submission was received.
What is the product code of K192612?
The FDA product code is NPL – Barrier, Animal Source, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.3930.