bonyf AG receives the EU-MDR Certification Class IIa for PerioCream

PerioCream, a mucoadhesive formulation based on NitrAdine®, has been granted a certification as a Class IIa medical device according to MDR (EU) 2017/745

bonyf NV (ENX:MLBON)

KNOKKE-HEIST, KNOKKE-HEIST, BELGIUM, October 16, 2025 /EINPresswire.com/ -- bonyf NV (Euronext Paris Ticker: MLBON), a leader in dental consumer goods, professional dental consumables and dermatological solutions, announces today that its brand, PerioCream, a mucoadhesive formulation based on NitrAdine^®, applied by dental professionals as an adjunct to Scaling & Root Planing (SRP) has been granted a certification as a Class IIa medical device according to Medical Device Regulation (EU) 2017/745 Annex IX Chapter I+III.

The certification, issued by DEKRA Certification GmbH, Germany, Notified Body (ID Number: 0124) on September the 17th, 2025, releases PerioCream Periodontal Paste to dental professionals and practitioners across the world.
The Medical Device Regulation (EU) 2017/745 is one of the world's most robust health tech regulations, and it plays a vital role in ensuring medical devices meet the highest standards.

It has replaced the Medical Device Directive (MDD) and brings a series of important improvements to conformity assessment for medical devices with the scope to ensure the quality, safety, performance and reliability of medical devices placed on the European Market; strengthen transparency of information related to medical devices for consumers and practitioners; enhance vigilance and market surveillance of devices in use. DEKRA Certification GmbH based in Germany with worldwide presence, is the notified Body of bonyf AG. We got the MDR certification from DEKRA including PerioCream, based on the sampling plan for reviews of class IIa devices.

For the UK market, European CE marking is currently accepted until specified deadlines and product risk classification. A UKRP (UK Representative) was already designated, and UK resellers can contact bonyf AG to obtain more information.
For the US market, bonyf AG initiated the certification process with FDA and currently bonyf AG is on track with expected certification by the US FDA beginning 2026.

What is PerioCream?
PerioCream Periodontal Paste is an adjunct to scaling and root planing (SRP) treatment applied by dental professionals on the gum line. PerioCream Periodontal Paste acts as a protective barrier by isolating inflamed gingiva and irritated oral tissues to prevent bacterial recolonization, help reduce bleeding and enhance natural healing. The product is clinically proven to significantly reduce pain after SRP, enhance patient comfort and improve the overall SRP experience.

About bonyf
bonyf NV is a Belgian Euronext Paris listed company (Ticker: MLBON) specialized in the development and distribution of high-quality oral and denture care products, serving both professional and consumer markets. Through its fully owned subsidiaries bonyf AG (Liechtenstein) and bonyf Production AG (Switzerland), the company is accelerating its international reach. With a focus on innovation, sustainability, and clinical performance, bonyf is rapidly expanding its footprint across Europe and North America.

https://www.cureus.com/articles/405117-adjunctive-use-of-periocream-following-scaling-and-root-planing-preliminary-findings-from-an-observational-clinical-study#!/
https://www.researchgate.net/publication/395639634_Adjunctive_Use_of_PerioCream_Following_Scaling_and_Root_Planing_Preliminary_Findings_From_an_Observational_Clinical_Study
https://bonyf.com/wp-content/uploads/2025/09/Zertifikat%20Nr.%2050537-60-00-02%20eng.pdf
https://zenodo.org/records/16921004

Jean-Pierre Bogaert
bonyf AG
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