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FDA 510(k)

SENDAX MDI (MINI DENTAL IMPLANT)

K-Number: K972351 · 1997-11-24

ApplicantSendax Mdic Management, Inc.
Decision Date1997-11-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SENDAX MDI (MINI DENTAL IMPLANT) is the device name listed in this FDA 510(k) record. The listed applicant is Sendax Mdic Management, Inc.. It received FDA 510(k) clearance on 1997-11-24 under 510(k) number K972351. 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 SENDAX MDI (MINI DENTAL IMPLANT)?

SENDAX MDI (MINI DENTAL IMPLANT) is a medical device that received FDA 510(k) clearance on 1997-11-24. The listed applicant is Sendax Mdic Management, Inc.. The 510(k) number is K972351.

When did SENDAX MDI (MINI DENTAL IMPLANT) receive FDA 510(k) clearance?

SENDAX MDI (MINI DENTAL IMPLANT) received FDA 510(k) clearance on 1997-11-24, under 510(k) number K972351.

Who is the listed applicant for SENDAX MDI (MINI DENTAL IMPLANT)?

The FDA 510(k) record lists Sendax Mdic Management, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENDAX MDI (MINI DENTAL IMPLANT)?

The FDA product code for SENDAX MDI (MINI DENTAL IMPLANT) is DZE.

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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.

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Official Source

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

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