SATALEC PIEZOTEC— 510(k) K852525

Name: FDA 510(k) clearance K852525
Creator: U.S. Food and Drug Administration
Published: 1986-01-30

Substantially Equivalent

Spelna, Inc.

FDA 510(k) clearance K852525 for SATALEC PIEZOTEC, Substantially Equivalent on 1986-01-30. Applicant: Spelna, Inc.. Device class: 2.

Clearance details

Applicant: Spelna, Inc.
Product code: Code ELC
Device class: Class 2
Regulation: 21 CFR 872.4850
Advisory panel: Dental
Date received: 1985-06-14
Decision date: 1986-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fredericksburg, VA, US

Download summary PDF View on FDA.gov ↗

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K852527 — SATALEC SEPTOSONIC SC 80/SC 1201986-01-03
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K853200 — 5X2 SATALEC CHIROPODY CASE1985-10-18
K852521 — SATLEC PROPHY UNIT PU 30551985-07-31
K852524 — SATALEC SERVOTORQUE S2 SX21985-07-31

Adverse events under product code ELC

product code ELC

Malfunction: 1,255
Total: 1,255

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.