510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Biodenta Swiss AG

Berneck Sankt Gallen, CH

BIODENTA SWISS AG appears in FDA device records in Berneck Sankt Gallen, CH. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 11 510(k) clearances for Biodenta Swiss AG between 2010 and 2015. The busiest year on record is 2013, with 4. The most recent is 2015, with 2.

Clearances by year, as a table
510(k) clearance decisions for Biodenta Swiss AG, by decision year
YearClearances
20102
20112
20134
20141
20152
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K151295Biodenta Customized Abutment - TitaniumNHASubstantially Equivalent
K150296Biodenta Customized Abutment-HybridNHASubstantially Equivalent
K133884BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MMDZESubstantially Equivalent
K123491BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENTNHASubstantially Equivalent
K122559BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTSNHASubstantially Equivalent
K123512BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MMDZESubstantially Equivalent
K123415BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPEREDDZESubstantially Equivalent
K111003BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVELDZESubstantially Equivalent
K110778BIODENTA CUSTOMIZED ABUTMENTNHASubstantially Equivalent
K093630BIODENTA DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K100150CERAMICS2IN1EIHSubstantially Equivalent

Registered establishments

FDA registered establishments for Biodenta Swiss AG, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30080885883008088588BIODENTA SWISS AGTramstrasse 16, Berneck Sankt Gallen 9442 CH2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Biodenta Swiss AG edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain