Endoform Dental Membrane
FDA 510(k) K231305 · Aroa Biosurgery , Ltd.
510(k) numberK231305
Submission
- Device name
- Endoform Dental Membrane
- Applicant
- Aroa Biosurgery , Ltd.
Auckland, NZ - Received
- May 5, 2023
- Decision date
- January 23, 2024
- 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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|---|---|---|
| K260669 | Endoform Dermal TemplateKGN · Traditional | 06/24/2026SE |
| K250598 | Endoform Reconstructive Template - PLGAFTM · Traditional | 06/03/2025SE |
| K223373 | EnivoBTA · Traditional | 04/07/2023SE |
| K200502 | Myriad ParticlesKGN · Traditional | 03/31/2021SE |
| K200413 | SymphonyKGN · Traditional | 07/29/2020SE |
| K183398 | Endoform RestellaFTM · Traditional | 04/11/2019SE |
| K181935 | Endoform Reconstructive Template - Non AbsorbableFTL · Traditional | 12/04/2018SE |
| K172318 | Endoform Silver Dermal TemplateFRO · Traditional | 11/17/2017SE |
| K171231 | Endoform Topical MatrixKGN · Traditional | 06/14/2017SE |
Questions and answers
When was Endoform Dental Membrane cleared by the FDA?
Endoform Dental Membrane (K231305) received a 510(k) decision of Substantially Equivalent on January 23, 2024, 263 days after the submission was received.
What is the product code of K231305?
The FDA product code is NPL – Barrier, Animal Source, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.3930.