Cleared Traditional

PROPHY ANGLE (K953628) - FDA 510(k) Clearance

Class I Dental device.

K953628 · Rolence Enterprise Co. , Ltd. · Dental device
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Sep 1995
Decision
60d
Days
Class 1
Risk

K953628 is an FDA 510(k) clearance for the PROPHY ANGLE. Classified as Cup, Prophylaxis (product code EHK), Class I - General Controls.

Submitted by Rolence Enterprise Co. , Ltd. (Chungli, Taiwan, TW). The FDA issued a Cleared decision on September 29, 1995 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6290 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rolence Enterprise Co. , Ltd. devices

Submission Details

510(k) Number K953628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1995
Decision Date September 29, 1995
Days to Decision 60 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
67d faster than avg
Panel avg: 127d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EHK Cup, Prophylaxis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6290
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.