← Back to catalogue
Heraeus' Heragam 48, Non Gamma 2 Den. Amal. Alloy
FDA 510(k)Class II (US FDA 510(k))
510(k) K875344
by Kulzer, Inc.
Identifiers
- 510(k) Number
- K875344 FDA 510(k)
- FDA Product Code
- EJJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3070 FDA 510(k)
- Regulation Number
- 872.3070 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Heraeus' Heragam 48, Non Gamma 2 Den. Amal. Alloy by Kulzer, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 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 | K875344 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kulzer, Inc.
Sources (1)
- FDA 510(k) K875344 24 fields · synced Jun 18, 2026