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Ora 0.4mm [s], Ora 1.0mm [s], Ora 2.0mm [s], Ora 3.0mm [s], Ora 4.0mm [s]
FDA 510(k)Class II (US FDA 510(k))
510(k) K133791
Identifiers
- 510(k) Number
- K133791 FDA 510(k)
- FDA Product Code
- NHA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3630 FDA 510(k)
- Regulation Number
- 872.3630 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Ora 0.4mm [s], Ora 1.0mm [s], Ora 2.0mm [s], Ora 3.0mm [s], Ora 4.0mm [s] by Sterngold Dental LLC — Class II — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133791 | Class II | Active |
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Manufacturer
- Manufacturer
- Sterngold Dental LLC
- FDA Applicant
- Sterngold Dental, LLC
Sources (1)
- FDA 510(k) K133791 24 fields · synced Jun 18, 2026