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FDA 510(k)

Disposable Prophy Angle (3399-60, 3399-090, 3399-105)

K-Number: K251869 · 2025-09-15

ApplicantPremium Plus (Dongguan) Limited
Decision Date2025-09-15
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Disposable Prophy Angle (3399-60, 3399-090, 3399-105) is a medical device manufactured by Premium Plus (Dongguan) Limited. It received FDA 510(k) clearance on 2025-09-15 under approval number K251869. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Prophy Angle (3399-60, 3399-090, 3399-105)?

Disposable Prophy Angle (3399-60, 3399-090, 3399-105) is a medical device that received FDA 510(k) clearance on 2025-09-15. It is manufactured by Premium Plus (Dongguan) Limited. The 510(k) number is K251869.

When was Disposable Prophy Angle (3399-60, 3399-090, 3399-105) approved by the FDA?

Disposable Prophy Angle (3399-60, 3399-090, 3399-105) received FDA 510(k) clearance on 2025-09-15, under approval number K251869.

What company makes Disposable Prophy Angle (3399-60, 3399-090, 3399-105)?

Disposable Prophy Angle (3399-60, 3399-090, 3399-105) is manufactured by Premium Plus (Dongguan) Limited.

What is the FDA product code for Disposable Prophy Angle (3399-60, 3399-090, 3399-105)?

The FDA product code for Disposable Prophy Angle (3399-60, 3399-090, 3399-105) is EGS.

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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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