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FDA 510(k)

SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES

K-Number: K063302 · 2006-11-15

ApplicantShanghai Dental Instrument Factory
Decision Date2006-11-15
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Dental Instrument Factory. It received FDA 510(k) clearance on 2006-11-15 under 510(k) number K063302. 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 SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES?

SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2006-11-15. The listed applicant is Shanghai Dental Instrument Factory. The 510(k) number is K063302.

When did SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES receive FDA 510(k) clearance?

SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES received FDA 510(k) clearance on 2006-11-15, under 510(k) number K063302.

Who is the listed applicant for SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES?

The FDA 510(k) record lists Shanghai Dental Instrument Factory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES?

The FDA product code for SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES is EIA.

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Other records listing Shanghai Dental Instrument Factory 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.

K063110CST61 HIGH SPEED TURBINE 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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