# K033938: Clearfil Protect Bond

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Jan 29, 2004 after 41 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: 1 generation back to K832497 (1983). 5 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974202: Pulpdent Cavity Cleanser, Pulpdent Cavity Cleanser Plus, Pulpdent Corp. (1998) Summary page 2.
- K915668: Bisco Cavity Cleanser, Bisco, Inc. (1992) Summary page 2.
- K832497: Cavity Cleanser, Den-Mat Corp. (1983) Summary page 2.
- K925375: Consepsis Scrub, Ultradent Products, Inc. (1993) Summary page 2.
- K924982: Consepsis (TM), Ultradent Products, Inc. (1993) Summary page 2.

## Most influential descendants
- K150704: PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer (2015), 2 descendants of its own
- K210504: PANAVIA Veneer LC (2021), 0 descendants of its own
- K191524: Visalys Tooth Primer (2019), 0 descendants of its own
- K183391: Novidia Universal Bond (2019), 0 descendants of its own

## Indications for use
The CLEARFIL PROTECT BOND device is indicated for the following applications: 1) direct restorations using light-cured composite resin or compomer 2) cavity sealing as a pretreatment for indirect restorations 3) treatment of hypersensitive 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/K033938
Methodology: https://510kreport.com/methodology