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

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..

Clearance details

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

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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.