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FDA 510(k)

PF Keep; Cad Cam Keep Block

K-Number: K233171 · 2023-11-27

ApplicantClemde SA DE CV
Decision Date2023-11-27
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PF Keep; Cad Cam Keep Block is the device name listed in this FDA 510(k) record. The listed applicant is Clemde SA DE CV. It received FDA 510(k) clearance on 2023-11-27 under 510(k) number K233171. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PF Keep; Cad Cam Keep Block?

PF Keep; Cad Cam Keep Block is a medical device that received FDA 510(k) clearance on 2023-11-27. The listed applicant is Clemde SA DE CV. The 510(k) number is K233171.

When did PF Keep; Cad Cam Keep Block receive FDA 510(k) clearance?

PF Keep; Cad Cam Keep Block received FDA 510(k) clearance on 2023-11-27, under 510(k) number K233171.

Who is the listed applicant for PF Keep; Cad Cam Keep Block?

The FDA 510(k) record lists Clemde SA DE CV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PF Keep; Cad Cam Keep Block?

The FDA product code for PF Keep; Cad Cam Keep Block is EBI.

Related Clinical Trials

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.

NCT07604142Allogenic Bone Block for Oro-Antral Communication Closure for Subsequent Implant PlacementENROLLING_BY_INVITATIONNCT07633574Additive vs Subtractive Manufacturing for Endocrown Fabrication: A 24-Month RCTNOT_YET_RECRUITING

Other records listing Clemde SA DE CV 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.

K242897Partial Flex

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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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