VITA ENAMIC Implant Solutions (IS)— 510(k) K153645

Clearance details

Applicant

Vita Zahnfabrik H.Rauter GmbH Co.

Product code

Code NHA

Device class

Class 2

Regulation

21 CFR 872.3630

Advisory panel

Dental

Date received

2015-12-21

Decision date

2016-06-30

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Bad Sackingen, DE

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• K253922 — Neodent Scannable Healing Abutment2026-06-15

• K243940 — VITA YZ Multi Translucent2025-02-21
• K180703 — VITA YZ ST and VITA YZ XT2018-08-01
• K152373 — VITA VM LC Flow2015-12-30
• K132070 — VITA SUPRINITY(R)2014-01-31
• K122269 — ENAMIC2012-12-13

Injury

1,270

Malfunction

2,860

Total

4,130

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 →