510(k) · Cleared
ClearedClearfil Protect Bond
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray Medical, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Jan 29, 2004 as substantially equivalent to K974202 (Pulpdent Corp., 1998) and 4 other predicates after a 41-day review. Its family tree reaches back 1 generation to 1983. 4 later devices descend from it.
- Decided
- Jan 29, 2004
- Review
- 41 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K832497 (1983). 5 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK832497 Cavity CleanserDen-Mat Corp. · 1983
- This deviceK033938 Clearfil Protect BondKuraray Medical, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK150704 PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear)…Kuraray Noritake Dental, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK210504 PANAVIA Veneer LCKuraray Noritake Dental, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK191524 Visalys Tooth PrimerKettenbach GmbH & Co. KG · 2019
- Descendant · cites it directly · 0 of its ownK183391 Novidia Universal BondNobio, Ltd. · 2019
Most influential descendants
Showing 4 of 4 · See all- K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc. · 2015 · cites it directly2descendants
- K210504PANAVIA Veneer LCKuraray Noritake Dental, Inc. · 2021 · 2 generations on0descendants
- K191524Visalys Tooth PrimerKettenbach GmbH & Co. KG · 2019 · 2 generations on0descendants
- K183391Novidia Universal BondNobio, Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832497 | Cavity Cleanser | Den-Mat Corp. | 1983 | — |
| 0 (this device) | K033938 | Clearfil Protect Bond | Kuraray Medical, Inc. | 2004 | — |
| +1 | K150704 | PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory… | Kuraray Noritake Dental, Inc. | 2015 | — |
| +2 | K210504 | PANAVIA Veneer LC | Kuraray Noritake Dental, Inc. | 2021 | — |
| +2 | K191524 | Visalys Tooth Primer | Kettenbach GmbH & Co. KG | 2019 | — |
| +1 | K183391 | Novidia Universal Bond | Nobio, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KLE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KLE device
- #1 K262252 MPa Max adhesivescore 15.1 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K974202 | Pulpdent Cavity Cleanser, Pulpdent Cavity Cleanser PlusSummary page 2…groups of dental resin material without MDPB. CLEARFIL PROTECT BOND is substantially equivalent for purposes of FDA market authorization to Pulpdent Cavity Cleanser (K#974202), Bisco Cavity Cleanser (K#915668), Den-Mat Cavity Cleanser (K#832497), and Ultradent Consepsis Cavity Varnish (K#925375 and K#92… | 1998 |
| * | K915668 | Bisco Cavity CleanserSummary page 2…ithout MDPB. CLEARFIL PROTECT BOND is substantially equivalent for purposes of FDA market authorization to Pulpdent Cavity Cleanser (K#974202), Bisco Cavity Cleanser (K#915668), Den-Mat Cavity Cleanser (K#832497), and Ultradent Consepsis Cavity Varnish (K#925375 and K#924982). Although the CLEARFIL PROTE… | 1992 |
| * | K832497 | Cavity CleanserSummary page 2…is substantially equivalent for purposes of FDA market authorization to Pulpdent Cavity Cleanser (K#974202), Bisco Cavity Cleanser (K#915668), Den-Mat Cavity Cleanser (K#832497), and Ultradent Consepsis Cavity Varnish (K#925375 and K#924982). Although the CLEARFIL PROTECT BOND device has a different antib… | 1983 |
| * | K925375 | Consepsis ScrubSummary page 2…ket authorization to Pulpdent Cavity Cleanser (K#974202), Bisco Cavity Cleanser (K#915668), Den-Mat Cavity Cleanser (K#832497), and Ultradent Consepsis Cavity Varnish (K#925375 and K#924982). Although the CLEARFIL PROTECT BOND device has a different antibacterial ingredient (MDPB), the biocompatibility st… | 1993 |
| * | K924982 | Consepsis (TM)Summary page 2…tion to Pulpdent Cavity Cleanser (K#974202), Bisco Cavity Cleanser (K#915668), Den-Mat Cavity Cleanser (K#832497), and Ultradent Consepsis Cavity Varnish (K#925375 and K#924982). Although the CLEARFIL PROTECT BOND device has a different antibacterial ingredient (MDPB), the biocompatibility studies submitt… | 1993 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 5 ancestors has a recall.
- Of its descendants, K150704 (Kuraray Noritake Dental, Inc., 2015) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KLE
149in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KLE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLE
3in 2025
MAUDE reports naming product code KLE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 71 | 2 | 18 |
| 2008 | 3 | 66 | 0 | 9 |
| 2009 | 7 | 79 | 1 | 11 |
| 2010 | 8 | 93 | 1 | 13 |
| 2011 | 10 | 100 | 0 | 69 |
| 2012 | 5 | 66 | 0 | 176 |
| 2013 | 11 | 115 | 0 | 248 |
| 2014 | 6 | 120 | 0 | 260 |
| 2015 | 10 | 118 | 0 | 100 |
| 2016 | 3 | 148 | 1 | 47 |
| 2017 | 4 | 171 | 1 | 42 |
| 2018 | 8 | 124 | 0 | 31 |
| 2019 | 6 | 143 | 0 | 20 |
| 2020 | 6 | 195 | 0 | 6 |
| 2021 | 4 | 163 | 0 | 6 |
| 2022 | 8 | 98 | 0 | 7 |
| 2023 | 6 | 75 | 0 | 7 |
| 2024 | 7 | 61 | 1 | 12 |
| 2025 | 3 | 149 | 0 | 3 |
| 2026 | 7 | 84 | 0 | — |
What is it indicated for?
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…
Read the full statement (102 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033938 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033938: Clearfil Protect Bond.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033938
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026