# K990381: Totalbond

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: May 17, 1999 after 98 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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 no predicate by number.

## Indications for use
Parkell’s TOTALBOND is a dual-curing adhesive cement, intended for use as a luting material for bonding inlays, onlays, crowns, and bridges to properly prepared teeth. It is also indicated for use as an agent for affecting repairs of tooth-colored veneers bonded to dental alloys, either non-precious or precious. For the latter instance, the supplied kit contains a noble metal-priming material which significantly increases the bond strength of the repair. The kit also contains a porcelain-primer that is recommended for use in repairing fractured dental porcelains. It mediates an adhesive bond between the porcelain substrate and an overlying composite resin.

Source page: https://510kreport.com/device/K990381
Methodology: https://510kreport.com/methodology