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iRoot BP Root Repair Material BioAggregate Paste - iRoot BP Plus Root Repair Material
FDA 510(k)Class II (US FDA 510(k))
510(k) K222992
Identifiers
- 510(k) Number
- K222992 FDA 510(k)
- FDA Product Code
- KIF FDA 510(k)
- Models / Variants
- iRoot FS Fast Set Root Repair Material FDA 510(k)iRoot BP Plus Root Repair Material FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3820 FDA 510(k)
- Regulation Number
- 872.3820 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
iRoot BP Root Repair Material BioAggregate Paste - iRoot BP Plus Root Repair Material by Innovative BioCeramix Inc. — Class II — FDA_510K — listed in FDA…
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 | K222992 | Class II | Active |
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Manufacturer
- Manufacturer
- Innovative BioCeramix Inc.
- FDA Applicant
- Innovative Bioceramix, Inc.
Sources (1)
- FDA 510(k) K222992 24 fields · synced Jun 18, 2026