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FDA 510(k)

DCI WATER PURIFIER

K-Number: K971727 · 1997-09-12

ApplicantDental Components, Inc.
Decision Date1997-09-12
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DCI WATER PURIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Dental Components, Inc.. It received FDA 510(k) clearance on 1997-09-12 under 510(k) number K971727. 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 DCI WATER PURIFIER?

DCI WATER PURIFIER is a medical device that received FDA 510(k) clearance on 1997-09-12. The listed applicant is Dental Components, Inc.. The 510(k) number is K971727.

When did DCI WATER PURIFIER receive FDA 510(k) clearance?

DCI WATER PURIFIER received FDA 510(k) clearance on 1997-09-12, under 510(k) number K971727.

Who is the listed applicant for DCI WATER PURIFIER?

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

What is the FDA product code for DCI WATER PURIFIER?

The FDA product code for DCI WATER PURIFIER is EIA.

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.

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Other records listing Dental Components, Inc. 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.

K033925BIOFREE

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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