# K013500: Kavo Polylux II

- Pathway: 510(k) (Traditional)
- Applicant: Kavo America
- Decided: Jan 14, 2002 after 84 days
- Product code: EBZ (Activator, Ultraviolet, For Polymerization)
- Device class: 2
- Regulation: 21 CFR 872.6070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) VIP-Variable Intensity Polymerizer (Bisco, Inc.): named in the summary without a submission number
- (no number) Elipar FreeLight (ESPE Dental AG): named in the summary without a submission number
- (no number) TriLight (ESPE Dental AG): named in the summary without a submission number
- (no number) Versalux (Centrix, Inc.): named in the summary without a submission number
- (no number) Palmlight: named in the summary without a submission number
- (no number) Optilux: named in the summary without a submission number
- (no number) Avanté (Jeneric/Pentron, Inc.): named in the summary without a submission number
- (no number) Coltolux 3 (Coltene/Whaledent AG): named in the summary without a submission number
- (no number) Coltolux 4 (Coltene/Whaledent AG): named in the summary without a submission number

## Indications for use
KaVo PolyLUX I is a handpiece for polymerization and is intended exclusively for dental treatment in regular dentistry.

Source page: https://510kreport.com/device/K013500
Methodology: https://510kreport.com/methodology