Cleared Traditional

K880827 - ACCUTEK PERIODONTAL PROBE

K880827 is an FDA 510(k) clearance for ACCUTEK PERIODONTAL PROBE, manufactured by Sweet Micro Systems, Inc.. The device is a Class 1 Dental device with product code EIX cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K880827 · Sweet Micro Systems, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1988
Decision
42d
Days
Class 1
Risk

K880827 is an FDA 510(k) clearance for the ACCUTEK PERIODONTAL PROBE. Classified as Probe, Periodontic (product code EIX), Class I - General Controls.

Submitted by Sweet Micro Systems, Inc. (Cranston, US). The FDA issued a Cleared decision on April 12, 1988 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Sweet Micro Systems, Inc. devices

FDA 510(k) Submission Details - K880827

510(k) Number K880827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1988
Decision Date April 12, 1988
Days to Decision 42 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 128d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

EIX Device Classification - Class 1, General Controls

Product Code EIX Probe, Periodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.