Heliomolar HB Translucent Shades
510(k) K013929
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013929 | Date7 Feb 2002 | StatusActive |
Official records
- FDA 510(k) database K013929
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBF
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Heliomolar HB Translucent Shades is a light-curing, radiopaque microfilled composite restorative material, classified as a dental filling material. It is designed for direct restorations in Class I and Class II cavities, providing a reinforced microfill structure for enhanced mechanical properties and aesthetic integration. The translucent formulation allows for precise shade matching and natural tooth appearance, while its microfilled composition ensures a smooth surface finish and high polish.
This material is supplied as a refill in 1x3 gram increments and is intended for single-use in dental procedures. It requires light activation for curing and is compatible with standard dental curing units. The product is regulated under FDA 510(k) clearance (K013929) and adheres to dental restorative standards, ensuring safety and performance for clinical applications. Storage should follow manufacturer guidelines to maintain sterility and material integrity.