Identifiers
- 510(k) Number
- K070147 FDA 510(k)
- FDA Product Code
- NUN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3930 FDA 510(k)
- Regulation Number
- 872.3930 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Intergro Oral is a bone grafting material, human source, designed for use as a bone filling material. It is indicated for dental intraosseous and oral/maxillofacial applications.
This device is regulated under FDA 510(k) clearance K070147. It is classified as a Class II medical device under regulation number 872.3930.
Frequently asked questions
What is the primary use of Intergro Oral?
Intergro Oral is a bone grafting material derived from a human source. It is specifically designed to function as a bone filling material for dental intraosseous procedures and various oral and maxillofacial applications.
How is this device regulated?
Intergro Oral is regulated as a Class II medical device under regulation number 872.3930. It received FDA 510(k) clearance under the number K070147, confirming it is substantially equivalent to other legally marketed devices.
Who is the manufacturer of this bone grafting material?
Intergro Oral is manufactured by Biomet 3i, located in Palm Beach Gardens, Florida. The device is categorized under the dental medical specialty and is identified by the product code NUN.
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: INTERGRO ORAL (K070147) — FDA 510 (k) | Innolitics, Biomet 3i™ Dental Implants | Preferred Dental Laboratory, PDF P)renta rket N oti fication -In terG ro®l Oral MAY 4 4T
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070147 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet 3i
Sources (1)
- FDA 510(k) K070147 24 fields · synced Sep 25, 2026