# K040599: Parkell Resin Glaze

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Apr 9, 2004 after 32 days
- Product code: EBD (Coating, Filling Material, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) belleGlaze: named in the summary without a submission number
- (no number) LuxaGlaze: named in the summary without a submission number
- (no number) Biscover XT: named in the summary without a submission number
- (no number) Biscover Polish: named in the summary without a submission number

## Most influential descendants
- K080549: Durafinish All-Cure, Model S296 (2008), 0 descendants of its own

## Indications for use
A nanofilled, light-cured, clear resin intended for use by a duly licensed professional as a glaze and sealant for composite resin restorations or for acrylic, bis-acryl and/or composite temporary materials. It can be used to impart high sheen and seal to appropriate surfaces without oxygen-inhibition and is expected to extend restoration durability and resistance to abrasive wear. This material is substantially equivalent to other FDA-certified devices (cited above) marketed in the USA. It functions in a manner similar to them and is intended for the same use as these predicate devices.

Source page: https://510kreport.com/device/K040599
Methodology: https://510kreport.com/methodology