Cleared Traditional

K100854 - PREMIUM PLUS DISPOSABLE PROPHY ANGLE MO...

K100854 is an FDA 510(k) clearance for PREMIUM PLUS DISPOSABLE PROPHY ANGLE MO..., manufactured by Premium Plus International Limited. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K100854 · Premium Plus International Limited · Dental device
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Dec 2010
Decision
258d
Days
Class 1
Risk

K100854 is an FDA 510(k) clearance for the PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Premium Plus International Limited (Hong Kong, CN). The FDA issued a Cleared decision on December 9, 2010 after a review of 258 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K100854

510(k) Number K100854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2010
Decision Date December 09, 2010
Days to Decision 258 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 127d · This submission: 258d
Pathway characteristics
Predicate-based equivalence.

EGS Device Classification - Class 1, General Controls

Product Code EGS Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EGS Handpiece, Contra- And Right-angle Attachment, Dental

All 23
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