PHASE CHANGE DENTAL LUBRICANT— 510(k) K954991

Substantially Equivalent

Phase Change

FDA 510(k) clearance K954991 for PHASE CHANGE DENTAL LUBRICANT, Substantially Equivalent on 1996-01-04. Applicant: Phase Change.

Clearance details

Applicant: Phase Change
Product code: Code EFB
Advisory panel: Dental
Date received: 1995-10-31
Decision date: 1996-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

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Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.