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FDA 510(k)

DENTO SPRAY ORAL IRRIGATOR

K-Number: K823305 · 1982-11-24

ApplicantNeo-Life Co. of America
Decision Date1982-11-24
Product CodeEFS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTO SPRAY ORAL IRRIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Neo-Life Co. of America. It received FDA 510(k) clearance on 1982-11-24 under 510(k) number K823305. The device is classified under product code EFS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTO SPRAY ORAL IRRIGATOR?

DENTO SPRAY ORAL IRRIGATOR is a medical device that received FDA 510(k) clearance on 1982-11-24. The listed applicant is Neo-Life Co. of America. The 510(k) number is K823305.

When did DENTO SPRAY ORAL IRRIGATOR receive FDA 510(k) clearance?

DENTO SPRAY ORAL IRRIGATOR received FDA 510(k) clearance on 1982-11-24, under 510(k) number K823305.

Who is the listed applicant for DENTO SPRAY ORAL IRRIGATOR?

The FDA 510(k) record lists Neo-Life Co. of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTO SPRAY ORAL IRRIGATOR?

The FDA product code for DENTO SPRAY ORAL IRRIGATOR is EFS.

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Related Devices (Code: EFS)

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.

K023232SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLESmartpracticeK001493DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001Air Force, Inc.K983374AGATHA-A-H2010Midian Intl.K964810DERMADAMUltradent Products, Inc.K952234BARRIER ALL FILMCottrell, Ltd.K943182ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOROral-B Laboratories

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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