SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS— 510(k) K960889

Name: FDA 510(k) clearance K960889
Creator: U.S. Food and Drug Administration
Published: 1996-05-10

Substantially Equivalent

San Diego Swiss Machining, Inc.

FDA 510(k) clearance K960889 for SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS, Substantially Equivalent on 1996-05-10. Applicant: San Diego Swiss Machining, Inc.. Device class: 2.

Clearance details

Applicant: San Diego Swiss Machining, Inc.
Product code: Code ELC
Device class: Class 2
Regulation: 21 CFR 872.4850
Advisory panel: Dental
Date received: 1996-03-04
Decision date: 1996-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ELC

view all

K260773 — Varios Combi Pro22026-03-10
K253254 — GBT Machine Airflow Prophylaxis Master2026-01-28
K251689 — VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10) +2 more2025-09-19
K242317 — Integrated Endo System (Meet Endo-II)2025-02-13
K233844 — OdneClean2024-08-08

More clearances from San Diego Swiss Machining, Inc.

view all

K934911 — SAPHIRE PLUS SURGICAL MIRROR1994-06-21

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.