Ultra-Lite 5 Turbo Light Cure Unit

FDA 510(k) K020874 · Rolence Ent., Inc.

Substantially Equivalent

510(k) numberK020874

Submission

Device name
Ultra-Lite 5 Turbo Light Cure Unit
Applicant
Rolence Ent., Inc.
Chungli, TW
Received
March 18, 2002
Decision date
June 12, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EBZ – Activator, Ultraviolet, For Polymerization
Device class
Class II (moderate risk)
Regulation
21 CFR 872.6070
Specialty
Dental

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Questions and answers

When was Ultra-Lite 5 Turbo Light Cure Unit cleared by the FDA?

Ultra-Lite 5 Turbo Light Cure Unit (K020874) received a 510(k) decision of Substantially Equivalent on June 12, 2002, 86 days after the submission was received.

What is the product code of K020874?

The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.