ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S]— 510(k) K133791

Clearance details

Applicant

Sterngold Dental, LLC

Product code

Code NHA

Device class

Class 2

Regulation

21 CFR 872.3630

Advisory panel

Dental

Date received

2013-12-13

Decision date

2014-04-16

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Attleboro, MA, US

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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 →