Cleared Traditional

K852524 - SATALEC SERVOTORQUE S2 SX2

K852524 is an FDA 510(k) clearance for SATALEC SERVOTORQUE S2 SX2, manufactured by Spelna, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K852524 · Spelna, Inc. · Dental device
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Jul 1985
Decision
47d
Days
Class 1
Risk

K852524 is an FDA 510(k) clearance for the SATALEC SERVOTORQUE S2 SX2. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Spelna, Inc. (Fredericksburg, US). The FDA issued a Cleared decision on July 31, 1985 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Spelna, Inc. devices

FDA 510(k) Submission Details - K852524

510(k) Number K852524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1985
Decision Date July 31, 1985
Days to Decision 47 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 128d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 - EIA Unit, Operative Dental

All 193
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K852524.
CM-II, CM-I WATER UNIT
K863021 · Sds Dental, Inc. · Oct 1986
EUROCART SR-4, EUROCART M-IV, ISOCART III
K863010 · Sds Dental, Inc. · Sep 1986
CABINET II AUXILIARY UNIT
K863023 · Sds Dental, Inc. · Sep 1986
SPACELINE DENTAL CHAIR-UNIT
K801685 · Pacific Dental Corp. · Aug 1980
MOBILE UNITS, I,II,III,IV
K790112 · Dentsply Intl. · Feb 1979