HARD RELINER— 510(k) K011277

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

2001-04-26

Decision date

2001-06-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Elmshorn, DE

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• K091735 — DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT2009-09-25
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• K083766 — PHOGLASS CEM2009-03-02
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• K081702 — CARBOXYLATE CEM, PHOSPHATE CEM2008-09-05

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 →