Vip 60 (2h) (115-000-1 +2 more)
FDA 510(k)Class II (US FDA 510(k))
by Micron Corp.
Identifiers
- 510(k) Number
- K991239 FDA 510(k)
- FDA Product Code
- ELC FDA 510(k)
- Models / Variants
- 115-000-1 FDA 510(k)Vip 60 (4h) FDA 510(k)Model 115-000-2 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4850 FDA 510(k)
- Regulation Number
- 872.4850 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vip 60 (2H) and Vip 60 (4H) are ultrasonic scalers used in dental procedures. These devices are designed to perform scaling functions as part of dental care.
These devices are classified as Class II medical devices under regulation number 872.4850. They were cleared for use via the FDA 510(k) process under K991239.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Vip 60 (2h), Model 115-000-1, Vip 60 (4h), Model 115-000-2, K991239 FDA 510 (k) - VIP 60 (2H) | Micron Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K991239 | Class II | Active |
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Manufacturer
- Manufacturer
- Micron Corp.
Sources (1)
- FDA 510(k) K991239 24 fields · synced Oct 6, 2026