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FDA 510(k)

WAVE

K-Number: K973091 · 1997-12-08

ApplicantSouthern Dental Industries, Inc.
Decision Date1997-12-08
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WAVE is the device name listed in this FDA 510(k) record. The listed applicant is Southern Dental Industries, Inc.. It received FDA 510(k) clearance on 1997-12-08 under 510(k) number K973091. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAVE?

WAVE is a medical device that received FDA 510(k) clearance on 1997-12-08. The listed applicant is Southern Dental Industries, Inc.. The 510(k) number is K973091.

When did WAVE receive FDA 510(k) clearance?

WAVE received FDA 510(k) clearance on 1997-12-08, under 510(k) number K973091.

Who is the listed applicant for WAVE?

The FDA 510(k) record lists Southern Dental Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WAVE?

The FDA product code for WAVE is EBF.

Other records listing Southern Dental Industries, Inc. as applicant

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Related Devices (Code: EBF)

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

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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