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FDA 510(k)

HU:500, HYGIENASSIST

K-Number: K771251 · 1977-07-15

ApplicantLitton Dental Products
Decision Date1977-07-15
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HU:500, HYGIENASSIST is the device name listed in this FDA 510(k) record. The listed applicant is Litton Dental Products. It received FDA 510(k) clearance on 1977-07-15 under 510(k) number K771251. 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 HU:500, HYGIENASSIST?

HU:500, HYGIENASSIST is a medical device that received FDA 510(k) clearance on 1977-07-15. The listed applicant is Litton Dental Products. The 510(k) number is K771251.

When did HU:500, HYGIENASSIST receive FDA 510(k) clearance?

HU:500, HYGIENASSIST received FDA 510(k) clearance on 1977-07-15, under 510(k) number K771251.

Who is the listed applicant for HU:500, HYGIENASSIST?

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

What is the FDA product code for HU:500, HYGIENASSIST?

The FDA product code for HU:500, HYGIENASSIST is EIA.

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Other records listing Litton Dental Products 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.

K791704MASTERSCALE IIK791024ULTRASONIC DENTAL PROPHYLAXIS UNITK781114ULTRAMATE 990K781044ULTRASONIC DENTAL PROPHYLAXIS UNIT,SSMK772244ILLUMINATED DENTAL HANDPIECEK771556EXR

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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