Regulatory and IP
Certificates
bonyf is certified according to ISO 9001:2015, EN ISO 13485:2016 and EU-MDR for the Quality Management System. Medical Device Class I and lla products are compliant with MDR 2017/745, Class IIb products are in transition from MDD to MDR.
See below bonyf’s current certifications.
ISO 9001:2015 – Certificate of Quality Management Systems
EN ISO 13485:2016 – Certificate of Medical Devices — Quality Management Systems
EC Certificate for the Quality Assurance System according to Directive 93/42/EEC
Kosher Certificate issued by Maor Hakashrut, Switzerland, issued 25 November 2022
FDA Listing Numbers
bonyf AG is registered with the Food and Drug Authority (“FDA”) in the USA. Registration Nr. 8020152.
To view real-time verification of listings: https://www.myfda.com/fda-md-reg/be179e36
The following products are listed with the FDA.
OlivaFix® Denture Adhesive Cream & OlivaFix® Gold Denture Adhesive Cream
| FDA Listing Number | D288590 |
|---|---|
| Premarket Submission Number (510K) | Exempt |
NitrAdine® Disinfecting Denture Tabs
| FDA Listing Number | E450448 |
|---|---|
| Premarket Submission Number (510K) | K051342 |
Superior Denture Adhesive Cream
| FDA Listing Number | B101364 |
|---|---|
| Premarket Submission Number (510K) | Exempt |
Denture Relining Cushion
| FDA Listing Number | D065601 |
|---|---|
| Premarket Submission Number (510K) | K971002 |
Patents
bonyf holds the following patents and patent applications on its products and formulations.
AphtoFix ®
| Patent No. | 2 777 708 |
|---|---|
| Region Patent Granted | Europe |
OlivaFix® Denture Adhesive Cream
| Patent No. | 2 525 768, 2 525 769 |
|---|---|
| Region Patent Granted | Europe |
| Patent No. | 8,871,828 |
|---|---|
| Region Patent Granted | USA |
| Patent No. | 338193 |
|---|---|
| Region Patent Granted | Mexico |
OlivaFix® Denture Adhesive Cream & OlivaFix® Gold Denture Adhesive Cream – Petrochemical free formulation
| Patent No. | 2 929 871 |
|---|---|
| Region Patent Granted | Europe |
PerioTabs®
| Patent Pending No. | 15 798 353.7 |
|---|---|
| Region Patent Pending | Europe |
| Patent Pending No. | 16/458,728 (divisional of 15/526,247) |
|---|---|
| Region Patent Pending | USA |
| Patent Pending No. | 1750/2014 |
|---|---|
| Region Patent Granted | Switzerland |
Trademarks
bonyf has the following trademarks registered worldwide.
| Trademark | Trademark Nos. (& Regions*) |
|---|---|
| BonyPLUS® | 459 729 (IB), 000434399 (EM), 37249 (SY) |
| OlivaFix® | 15618 (LI), 1061805 (IB), 4,219,864 (US) |
| AphtoFix® | 1180 766 (IB), 16631 (LI) |
| PerioTabs® | 18772 (LI), 302019204874 (DE), 1 494 682 (IB) |
| NitrAdine® | 911 105 (IB), 3,382,168 (US) |
*Trademark Region Codes
IB – INTERNATIONAL BUREAU OF THE WORLD INTELLECTUAL PROPERTY ORGANIZATION
EM — EUROPEAN UNION INTELLECTUAL PROPERTY OFFICE
SY – SYRIAN ARAB REPUBLIC
LI – LIECHTENSTEIN
DE – GERMANY
US – UNITED STATES OF AMERICA
Registered Brand Names
See below for a list of the trusted brands produced by bonyf, together with the bonyf products associated with each brand.
| Brand Logo | Products Associated With Brand |
|---|---|
 |
NitrAdine® Disinfecting Effervescent Denture Tabs NitrAdine® Ortho & Junior Effervescent Disinfecting Tabs |
   |
OlivaFix® Gold Denture Adhesive Cream OlivaFix® Regular Denture Adhesive Cream OlivaFix® Fresh Denture Adhesive Cream |
 |
PerioTabs® effervescent tablets to help reduce gingivitis, periodontitis, peri-mucositis, and peri-implantitis |
 |
AphtoFix® Mouth Ulcer Cream |
 |
Superior Denture Adhesive Cream Effervescent Denture Cleanser Tabs Denture Repair-fix Fixobridge Cavifix® Denture Relining Cushion |
  |
HeelFix paste dressing for cracks and chapped skin on heels and feet. FingerFix paste dressing for cracks and chapped skin on fingers and hands. |
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