Cleared Traditional

K953865 - SPACELINE FEEL 21

K953865 is an FDA 510(k) clearance for SPACELINE FEEL 21, manufactured by J. Morita USA, Inc.. The device is a Class 1 Dental device with product code EFA cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K953865 · J. Morita USA, Inc. · Dental device
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Mar 1996
Decision
216d
Days
Class 1
Risk

K953865 is an FDA 510(k) clearance for the SPACELINE FEEL 21. Classified as Handpiece, Belt And/or Gear Driven, Dental (product code EFA), Class I - General Controls.

Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on March 20, 1996 after a review of 216 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.

View all J. Morita USA, Inc. devices

FDA 510(k) Submission Details - K953865

510(k) Number K953865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1995
Decision Date March 20, 1996
Days to Decision 216 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 127d · This submission: 216d
Pathway characteristics
Predicate-based equivalence.

EFA Device Classification - Class 1, General Controls

Product Code EFA Handpiece, Belt And/or Gear Driven, 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.