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FDA 510(k)

INFECTION CONTROL CARTRIDGE

K-Number: K964942 · 1997-06-19

ApplicantDentalpure Corp.
Decision Date1997-06-19
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INFECTION CONTROL CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Dentalpure Corp.. It received FDA 510(k) clearance on 1997-06-19 under 510(k) number K964942. 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 INFECTION CONTROL CARTRIDGE?

INFECTION CONTROL CARTRIDGE is a medical device that received FDA 510(k) clearance on 1997-06-19. The listed applicant is Dentalpure Corp.. The 510(k) number is K964942.

When did INFECTION CONTROL CARTRIDGE receive FDA 510(k) clearance?

INFECTION CONTROL CARTRIDGE received FDA 510(k) clearance on 1997-06-19, under 510(k) number K964942.

Who is the listed applicant for INFECTION CONTROL CARTRIDGE?

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

What is the FDA product code for INFECTION CONTROL CARTRIDGE?

The FDA product code for INFECTION CONTROL CARTRIDGE 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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