# K972421: Easy Bond

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Aug 29, 1997 after 63 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- 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) Prime & Bond 2.1: named in the summary without a submission number
- (no number) Clearfil Liner Bond 2: named in the summary without a submission number
- (no number) Optibond: named in the summary without a submission number
- (no number) Syntac: named in the summary without a submission number

## Indications for use
For use as a tooth-bonding agent that seals patent dentinal tubules to reduce hypersensitivity and aids in the retention of tooth-colored dental restoratives when these are placed over EASY BOND that has been painted-onto prepared cavities.

Source page: https://510kreport.com/device/K972421
Methodology: https://510kreport.com/methodology