Calset Composite Heater
by Addent, Inc.
510(k) K061395
Calset Composite Heater is a Class II device made by Addent, Inc., cleared under FDA 510(k) K061395 on 23 Jun 2006, 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 | NumberK061395 | Date23 Jun 2006 | StatusActive |
Official records
- FDA 510(k) database K061395
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBZ
- Device class
- Class II
- Regulation
- 21 CFR Part 872.6070
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code EBZ (Activator, Ultraviolet, For Polymerization).
- Delight, Delight ortho, B&Lite S by Dentall co., Ltd.
- Radiance Curing Light by Air Techniques, Inc.
- LEDEX by Dentmate Technology Co., Ltd.
- VIP- VARIABLE INTENSITY POLYMERIZER by BISCO INC.
- TULUX-FILTER by Espe GmbH (Us)
- Curing Light (M-Cure 6) by Guangzhou RebornEndo Medical Instrument Co., Ltd.
- Valiant Curing Light by Inter-Med/Vista Dental Products
- CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676 by Rolence Enterprise Co., Ltd.
- PRISMA III by Dentsply Intl.
- SMARTLITE PS PEN-STYLE LED CURING LIGHT by Dentsply International