Poly-Lite Model 1000

FDA 510(k) K954061 · Pro-Den Systems, Inc.

Substantially Equivalent

510(k) numberK954061

Submission

Device name
Poly-Lite Model 1000
Applicant
Pro-Den Systems, Inc.
Vancouver, WA, US
Received
August 29, 1995
Decision date
September 21, 1995
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 Poly-Lite Model 1000 cleared by the FDA?

Poly-Lite Model 1000 (K954061) received a 510(k) decision of Substantially Equivalent on September 21, 1995, 23 days after the submission was received.

What is the product code of K954061?

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