Heliodent Plus
510(k) K083344
Heliodent Plus is a Class II device made by SIRONA Dental Systems GmbH, cleared under FDA 510(k) K083344 on 23 Dec 2008, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083344 | Date23 Dec 2008 | StatusActive |
Official records
- FDA 510(k) database K083344
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EHD
- Device class
- Class II
- Regulation
- 21 CFR Part 872.1800
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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