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SmartShape Healing Abutment - SmartShape™ Healing Abutment
FDA 510(k)Class II (US FDA 510(k))
510(k) K240531
Identifiers
- 510(k) Number
- K240531 FDA 510(k)
- FDA Product Code
- NHA FDA 510(k)
- Models / Variants
- SmartShape™ Healing Abutment FDA 510(k)Wide Custom Milled Ti-Blank Abutment 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)
SmartShape Healing Abutment - SmartShape™ Healing Abutment by BioHorizons Implant Systems, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 2 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 | K240531 | Class II | Active |
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Manufacturer
- Manufacturer
- BioHorizons Implant Systems, Inc.
Sources (1)
- FDA 510(k) K240531 24 fields · synced Jun 19, 2026