A-SOFT RELINER— 510(k) K984483

Clearance details

Applicant

S & C Polymer GmbH

Product code

Code EBI

Device class

Class 2

Regulation

21 CFR 872.3760

Advisory panel

Dental

Date received

1998-12-16

Decision date

1999-02-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Elmshorn, DE

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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 →