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FDA 510(k)

CEREC Tessera Abutment System

K-Number: K252248 · 2025-11-26

ApplicantDentsply Sirona
Decision Date2025-11-26
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CEREC Tessera Abutment System is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2025-11-26 under 510(k) number K252248. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEREC Tessera Abutment System?

CEREC Tessera Abutment System is a medical device that received FDA 510(k) clearance on 2025-11-26. The listed applicant is Dentsply Sirona. The 510(k) number is K252248.

When did CEREC Tessera Abutment System receive FDA 510(k) clearance?

CEREC Tessera Abutment System received FDA 510(k) clearance on 2025-11-26, under 510(k) number K252248.

Who is the listed applicant for CEREC Tessera Abutment System?

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

What is the FDA product code for CEREC Tessera Abutment System?

The FDA product code for CEREC Tessera Abutment System is NHA.

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Related Devices (Code: NHA)

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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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