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Biodenta Swiss AG: FDA-registered device maker in Berneck Sankt Gallen, Switzerland, 9 510(k) clearances

Name: Biodenta Swiss AG FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Biodenta Swiss AG is registered with the FDA (registration 3008088588) in Berneck Sankt Gallen, Switzerland. It lists 3 device types. The FDA files 9 510(k) clearances under its listings, the newest dated December 1, 2015. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008088588
Address: Tramstrasse 16, Berneck Sankt Gallen, Switzerland, 9442
Owner or operator: Biodenta Swiss AG (10030896)
Roles: Specification developer
First device listed: August 23, 2010
Registered through: 2026
Brand names listed: Biodenta / DentaSwiss Scanbody, Biodenta Customized Abutment - Hybrid, Biodenta Customized Abutment - Titanium, Biodenta Dental Implant System, Biodenta Dental Implant System (Bone Level Tapered), Biodenta Dental Implant System (Bone Level), Biodenta Dental Implant System - Abutments, Biodenta Dental Implant System - Bone Level D 3 to 6 mm and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Specification developer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Specification developer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 1, 2015	K151295	Biodenta Customized Abutment - Titanium	NHA	Substantially Equivalent	Biodenta Swiss AG	accessdata.fda.gov
July 2, 2015	K150296	Biodenta Customized Abutment-Hybrid	NHA	Substantially Equivalent	Biodenta Swiss AG	accessdata.fda.gov
June 13, 2014	K133884	BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM	DZE	Substantially Equivalent	Biodenta Swiss AG	accessdata.fda.gov
May 30, 2013	K123491	BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT	NHA	Substantially Equivalent	Biodenta Swiss AG	accessdata.fda.gov
May 3, 2013	K122559	BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS	NHA	Substantially Equivalent	Biodenta Swiss AG	accessdata.fda.gov
March 28, 2013	K123512	BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM	DZE	Substantially Equivalent	Biodenta Swiss AG	accessdata.fda.gov
March 19, 2013	K123415	BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED	DZE	Substantially Equivalent	Biodenta Swiss AG	accessdata.fda.gov
September 15, 2011	K111003	BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL	DZE	Substantially Equivalent	Biodenta Swiss AG	accessdata.fda.gov
June 3, 2010	K093630	BIODENTA DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Biodenta Swiss AG	accessdata.fda.gov

Compare with other makers

Updated December 1, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.