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FDA 510(k)

PORTA'PURE/DENTAL

K-Number: K961409 · 1996-06-12

ApplicantWater Solution Technologies
Decision Date1996-06-12
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PORTA'PURE/DENTAL is the device name listed in this FDA 510(k) record. The listed applicant is Water Solution Technologies. It received FDA 510(k) clearance on 1996-06-12 under 510(k) number K961409. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTA'PURE/DENTAL?

PORTA'PURE/DENTAL is a medical device that received FDA 510(k) clearance on 1996-06-12. The listed applicant is Water Solution Technologies. The 510(k) number is K961409.

When did PORTA'PURE/DENTAL receive FDA 510(k) clearance?

PORTA'PURE/DENTAL received FDA 510(k) clearance on 1996-06-12, under 510(k) number K961409.

Who is the listed applicant for PORTA'PURE/DENTAL?

The FDA 510(k) record lists Water Solution Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTA'PURE/DENTAL?

The FDA product code for PORTA'PURE/DENTAL is EIA.

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Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

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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