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FDA 510(k)

BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM

K-Number: K123512 · 2013-03-28

ApplicantBiodenta Swiss AG
Decision Date2013-03-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM is the device name listed in this FDA 510(k) record. The listed applicant is Biodenta Swiss AG. It received FDA 510(k) clearance on 2013-03-28 under 510(k) number K123512. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM?

BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM is a medical device that received FDA 510(k) clearance on 2013-03-28. The listed applicant is Biodenta Swiss AG. The 510(k) number is K123512.

When did BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM receive FDA 510(k) clearance?

BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM received FDA 510(k) clearance on 2013-03-28, under 510(k) number K123512.

Who is the listed applicant for BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM?

The FDA 510(k) record lists Biodenta Swiss AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM?

The FDA product code for BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM is DZE.

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Other records listing Biodenta Swiss AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123491BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENTK122559BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTSK123415BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPEREDK111003BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVELK110778BIODENTA CUSTOMIZED ABUTMENTK093630BIODENTA DENTAL IMPLANT SYSTEM

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Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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