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A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE - Te-97
FDA 510(k)Class I (US FDA 510(k))
510(k) K082716
by A-Dec, Inc.
Identifiers
- 510(k) Number
- K082716 FDA 510(k)
- FDA Product Code
- EFB FDA 510(k)
- Models / Variants
- Te-97 FDA 510(k)Te-98 FDA 510(k)A-Dec FDA 510(k)W FDA 510(k)H Alegra Handpiece Attachment FDA 510(k)Model He-43 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)
A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE - Te-97 by A-Dec, Inc. — Class I — FDA_510K — listed in FDA 510(k) — 6 models — regulatory data on deviCERTS
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 | K082716 | Class I | Active |
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Manufacturer
- Manufacturer
- A-Dec, Inc.
Sources (1)
- FDA 510(k) K082716 24 fields · synced Jun 18, 2026