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FDA 510(k)

DESS Dental Implants

K-Number: K212538 · 2021-12-14

Decision Date2021-12-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DESS Dental Implants is the device name listed in this FDA 510(k) record. The listed applicant is Terrats Medical SL. It received FDA 510(k) clearance on 2021-12-14 under 510(k) number K212538. 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 DESS Dental Implants?

DESS Dental Implants is a medical device that received FDA 510(k) clearance on 2021-12-14. The listed applicant is Terrats Medical SL. The 510(k) number is K212538.

When did DESS Dental Implants receive FDA 510(k) clearance?

DESS Dental Implants received FDA 510(k) clearance on 2021-12-14, under 510(k) number K212538.

Who is the listed applicant for DESS Dental Implants?

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

What is the FDA product code for DESS Dental Implants?

The FDA product code for DESS Dental Implants is DZE.

Other records listing Terrats Medical SL 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.

View all 23 devices →

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.

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.