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FDA 510(k)

DENTAL UNIT WITH CHAIR

K-Number: K080438 · 2008-04-04

ApplicantNorth West Medical Instrument (Group) Co., Ltd.
Decision Date2008-04-04
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL UNIT WITH CHAIR is the device name listed in this FDA 510(k) record. The listed applicant is North West Medical Instrument (Group) Co., Ltd.. It received FDA 510(k) clearance on 2008-04-04 under 510(k) number K080438. 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 DENTAL UNIT WITH CHAIR?

DENTAL UNIT WITH CHAIR is a medical device that received FDA 510(k) clearance on 2008-04-04. The listed applicant is North West Medical Instrument (Group) Co., Ltd.. The 510(k) number is K080438.

When did DENTAL UNIT WITH CHAIR receive FDA 510(k) clearance?

DENTAL UNIT WITH CHAIR received FDA 510(k) clearance on 2008-04-04, under 510(k) number K080438.

Who is the listed applicant for DENTAL UNIT WITH CHAIR?

The FDA 510(k) record lists North West Medical Instrument (Group) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTAL UNIT WITH CHAIR?

The FDA product code for DENTAL UNIT WITH CHAIR is EIA.

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Other records listing North West Medical Instrument (Group) Co., Ltd. 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.

K093971DENTAL HANDPIECE

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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