Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®
FDA 510(k) K252253 · Geistlich Pharma AG
510(k) numberK252253
Submission
- Device name
- Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®
- Applicant
- Geistlich Pharma AG
Wolhusen, CH - Received
- July 21, 2025
- Decision date
- November 25, 2025
- 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.
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More from Kerecis
| 510(k) | Device | Decision |
|---|---|---|
| K260364 | Device 300419 StripMQV · Traditional | 06/02/2026SE |
| K260532 | Derma-GideKGN · Special | 03/19/2026SE |
| K251323 | Device 104 ParticulateKGN · Traditional | 01/22/2026SE |
| K251062 | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich…NPL · Traditional | 08/14/2025SE |
| K251556 | Device 300423 GranulesMQV · Traditional | 07/17/2025SE |
| K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®NPM · Special | 07/11/2025SE |
| K251613 | SwissGraft XNPM · Special | 06/26/2025SE |
| K250833 | SwissMembrane X; SwissMembrane X SocketNPL · Special | 04/15/2025SE |
| K242510 | Geistlich Bio-Flow®NPM · Traditional | 03/07/2025SE |
| K241802 | Device 300397 PuttyMQV · Traditional | 11/08/2024SE |
Questions and answers
When was Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® cleared by the FDA?
Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® (K252253) received a 510(k) decision of Substantially Equivalent on November 25, 2025, 127 days after the submission was received.
What is the product code of K252253?
The FDA product code is NPL – Barrier, Animal Source, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.3930.