# K183391: Novidia Universal Bond

- Pathway: 510(k) (Traditional)
- Applicant: Nobio, Ltd.
- Decided: Sep 24, 2019 after 291 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
Longest line of descent: 8 generations back to K931812 (1993). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023842: Clearfil SE Bond Plus, Kuraray Medical, Inc. (2003) Summary page 4.
- K033938: Clearfil Protect Bond, Kuraray Medical, Inc. (2004) Summary page 4.

## Indications for use
Novidia™ Universal Bond is indicated for use in: 1) Direct restorations using light-cured composite resin or compomer 2) Cavity sealing as a pretreatment for indirect restorations 3) Treatment of hypersensitive teeth and/or exposed root surfaces 4) Intraoral repairs of fractured crowns/bridges made of porcelain, hybrid ceramics, or composite resin using light-cured composite resin 5) Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics, or cured composite resin 6) Core build-ups using light- or dual-cured composite resin 7) Cavity sealing under amalgam restorations ** For indications 1, 2, 3, 6, and 7 the device exhibits an antibacterial cavity cleansing effect.

Source page: https://510kreport.com/device/K183391
Methodology: https://510kreport.com/methodology