Litex 680
by Dentamerica
510(k) K955759
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK955759 | Date2 Jan 1996 | StatusActive |
Official records
- FDA 510(k) database K955759
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- Withdrawn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
Overview
AI-generated summary, 27 Sep 2026
The Litex 680 is an ultraviolet activator used for polymerization in dental applications. This device functions as a light curing unit designed to facilitate the hardening of dental materials.
This device is a gun-type unit featuring a 75-watt, 12V tungsten halogen lamp and a 9mm standard probe. It includes an internally-mounted fan for continuous operation and an automatic timer that allows for preselection of cure times between 10 and 60 seconds. The device is authorized via FDA 510(k) clearance.
Devices cleared under K955759
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| LITEX 680A | 680A | 00858466005172 | — | On the market |
| LITEX 686 | 686 | 00858466005226 | — | On the market |
| LITEX 695 | 695 | 00858466005189 | — | On the market |
| LITEX 696 | 696 | 00858466005196 | — | On the market |
| LITEX 696T | 696T | 00858466005202 | — | On the market |
Similar devices
Other devices filed under FDA product code EBZ (Activator, Ultraviolet, For Polymerization).
- Clear Blue Digi LED Curing Light by Promident, LLC
- INSTANT CURE-1 by Ultra-Light Corp.
- SUNLITELED MODEL #2810 by Kinetic Instruments, Inc.
- MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI by Satelec
- LYSTA LC CURING LIGHT, MODEL LC 2500C/BA by Lysta A/S
- FUSION CURING LIGHT by DENTLIGHT INC.
- BLUEPHASE by Ivoclar Vivadent, Inc.
- NUVA-LITE II PHOTO-CURE UNIT by Dentsply Intl.
- LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA by Lysta A/S
- OP II VISIBLE LIGHT CURING SYSTEM by Almore Intl., Inc.