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FDA 510(k)

CERAMICS2IN1

K-Number: K100150 · 2010-05-25

ApplicantBiodenta Swiss AG
Decision Date2010-05-25
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERAMICS2IN1 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 2010-05-25 under 510(k) number K100150. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERAMICS2IN1?

CERAMICS2IN1 is a medical device that received FDA 510(k) clearance on 2010-05-25. The listed applicant is Biodenta Swiss AG. The 510(k) number is K100150.

When did CERAMICS2IN1 receive FDA 510(k) clearance?

CERAMICS2IN1 received FDA 510(k) clearance on 2010-05-25, under 510(k) number K100150.

Who is the listed applicant for CERAMICS2IN1?

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 CERAMICS2IN1?

The FDA product code for CERAMICS2IN1 is EIH.

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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 - ABUTMENTSK123512BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MMK123415BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPEREDK111003BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVELK110778BIODENTA CUSTOMIZED ABUTMENT

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Related Devices (Code: EIH)

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.

K262074Any-ZircosMediclus Co., Ltd.K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.

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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