Cleared Traditional

K852522 - SATALEC SERVOTOME

K852522 is an FDA 510(k) clearance for SATALEC SERVOTOME, manufactured by Spelna, Inc.. The device is a Class 2 Dental device with product code EKZ cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K852522 · Spelna, Inc. · Dental device
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Dec 1985
Decision
196d
Days
Class 2
Risk

K852522 is an FDA 510(k) clearance for the SATALEC SERVOTOME. Classified as Unit, Electrosurgical, And Accessories, Dental (product code EKZ), Class II - Special Controls.

Submitted by Spelna, Inc. (Fredericksburg, US). The FDA issued a Cleared decision on December 27, 1985 after a review of 196 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4920 - 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 Spelna, Inc. devices

FDA 510(k) Submission Details - K852522

510(k) Number K852522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1985
Decision Date December 27, 1985
Days to Decision 196 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 128d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EKZ Device Classification - Class 2, Special Controls

Product Code EKZ Unit, Electrosurgical, And Accessories, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EKZ Unit, Electrosurgical, And Accessories, Dental

All 13
Devices cleared under the same product code (EKZ) and FDA review panel - the closest regulatory comparables to K852522.
ARTHROCARE DENTAL ELECTROSURGERY SYSTEM
K962445 · Arthrocare Corp. · Jul 1996
DENTO-SURGE
K955176 · Ellman Intl., Inc. · Apr 1996
SENSIMATIC 500SE
K950239 · Parkell, Inc. · Jun 1995
STROBEX ULTRON ELECTROSURGE-DENTAL UNIT
K850666 · Ipco Corp. · May 1985
DIFF 4 SYSTEM
K830441 · Coulter Electronics, Inc. · May 1983