EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA— 510(k) K853094

Substantially Equivalent

Psp Dental Co., Ltd.

FDA 510(k) clearance K853094 for EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA, Substantially Equivalent on 1986-04-04. Applicant: Psp Dental Co., Ltd..

Clearance details

Applicant: Psp Dental Co., Ltd.
Product code: Code EBI
Advisory panel: Dental
Date received: 1985-07-23
Decision date: 1986-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belvedere, Kent, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

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.