Regulatory and IP

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 2021

FDA Listing Numbers

bonyf AG is registered with the Food and Drug Authority (“FDA”) in the USA with the Registration Number 8020152. The current registration expires on 31 December 2022 and is renewed on an annual basis.

The following products are listed with the FDA.

OlivaFix® Denture Adhesive Cream & OlivaFix® Gold Denture Adhesive Cream

Listing Number D288590
Premarket Submission Number (510K) Exempt

NitrAdine® Disinfecting Denture Tabs

Listing Number E450448
Premarket Submission Number (510K) K051342

Superior Denture Adhesive Cream

Listing Number B101364
Premarket Submission Number (510K) Exempt

Denture Relining Cushion

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

NitrAdine® Disinfecting Denture Tabs

Patent No. 1 523 239
Region Patent Granted Europe

NitrAdine® Ortho & Junior Disinfecting Tabs

Patent No. 1 523 239
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.