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FDA 510(k)

DP32 HAND HELD DENTAL PROPHYLAXIS UNIT

K-Number: K861601 · 1986-10-17

ApplicantStewart J. Lustgarten
Decision Date1986-10-17
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DP32 HAND HELD DENTAL PROPHYLAXIS UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Stewart J. Lustgarten. It received FDA 510(k) clearance on 1986-10-17 under 510(k) number K861601. 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 DP32 HAND HELD DENTAL PROPHYLAXIS UNIT?

DP32 HAND HELD DENTAL PROPHYLAXIS UNIT is a medical device that received FDA 510(k) clearance on 1986-10-17. The listed applicant is Stewart J. Lustgarten. The 510(k) number is K861601.

When did DP32 HAND HELD DENTAL PROPHYLAXIS UNIT receive FDA 510(k) clearance?

DP32 HAND HELD DENTAL PROPHYLAXIS UNIT received FDA 510(k) clearance on 1986-10-17, under 510(k) number K861601.

Who is the listed applicant for DP32 HAND HELD DENTAL PROPHYLAXIS UNIT?

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

What is the FDA product code for DP32 HAND HELD DENTAL PROPHYLAXIS UNIT?

The FDA product code for DP32 HAND HELD DENTAL PROPHYLAXIS UNIT 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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