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Mach-Sigma Handpiece, Ultrapush (Mach-Sigma Mu (mini Head) +2 more)
FDA 510(k)Class I (US FDA 510(k))
510(k) K991701
Identifiers
- 510(k) Number
- K991701 FDA 510(k)
- FDA Product Code
- EFB FDA 510(k)
- Models / Variants
- Mach-Sigma Mu (mini Head) FDA 510(k)Mach-Sigma Su (std. Head) FDA 510(k)Mach-Sigma Tu (torque Hd) FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4200 FDA 510(k)
- Regulation Number
- 872.4200 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Mach-Sigma Handpiece, Ultrapush (Mach-Sigma Mu (mini Head) +2 more) by Nsk Nakanishi, Inc. — Class I — FDA_510K — listed in FDA 510(k) — 3 models
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 | K991701 | Class I | Active |
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Manufacturer
- Manufacturer
- Nsk Nakanishi, Inc.
Sources (1)
- FDA 510(k) K991701 24 fields · synced Jun 18, 2026