510(k) · Cleared
ClearedSurface Coat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray America, Inc. · EBD Coating, Filling Material, Resin
Cleared on Dec 8, 2006 as substantially equivalent to K030354 (Bisco, Inc., 2003) and 4 other predicates after a 44-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Dec 8, 2006
- Review
- 44 days
- Class
- Class II
- Product code
- EBD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K931812 (1993). 30 ancestors in all, the oldest K871636 (1987). No later device cites it as a predicate yet.
- Root · 8 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 7 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 6 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 5 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 4 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
- 3 generations backK990040 Clearfil SE BondKuraray Co. · 1999
- 2 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- 1 generation backK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
- This deviceK063228 Surface CoatKuraray America, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −7 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −6 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −5 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −4 | K974486 | Clearfil Liner Bond 2V | Kuraray America, Inc. | 1998 | — |
| −3 | K990040 | Clearfil SE Bond | Kuraray Co. | 1999 | — |
| −2 | K012442 | Modification to Clearfil SE Bond | Kuraray Medical, Inc. | 2001 | — |
| −1 | K032455 | Panavia F 2.0 | Kuraray Medical, Inc. | 2003 | — |
| 0 (this device) | K063228 | Surface Coat | Kuraray America, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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 EBD? 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 EBD device
- #1 K254091 Glossy Coat (15ML)score 11.4 · 2 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 |
|---|---|---|---|
| * | K030354 | Biscover Liquid Polish Kit, Biscover Liquid Polish and Biscover Viscosity ModifierSummary page 1…uct code: EBD) 3) Common name Resin glaze material 3. Predicate device 1) BISCOVER LIQUID POLISH 510(k) Number: K030354 Product Code: EBD 21 CFR Sect… | 2003 |
| * | K043168 | Biscover LVSummary page 1…tion: 872.3310 Applicant: BISCO, INC. 2) BISCOVER LV 510(k) Number: K043 168 Product Code: EBD 21 CFR Sect… | 2005 |
| * | K960464 | C & B Metabond (Modification)Summary page 1…tion: 872.3310 Applicant: BISCO, INC. 3) C&B METABOND 51 0(k) Number: K960464 Product Code: EMA 21 CFR Sect… | 1996 |
| * | K012737 | Chroma Zone Color StainSummary page 1…n: 872.3275 Applicant: PARKELL, INC. 4) CHROMA ZONE COLOR STAIN 510(k) Number: K012737 Product Code: EBF 21 CFR Sec… | 2001 |
| * | K032455 | Panavia F 2.0Summary page 1…872.3690 Applicant: KURARAY MEDICAL, INC. 5) PANAVIA F 2.0 510(k) Number: K032455 Product Code: EMA 21 CFR Sec… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 30 ancestors has a recall.
- 1 other device also cites its predicate K030354.
How does its category compare?
All EBD devicesEBD Coating, Filling Material, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBD
76in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBD
No recall names EBD since 2007.
Adverse event reports per year · EBD
5in 2023
MAUDE reports naming product code EBD, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 76 | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
SURFACE COAT is used to glaze/polish following restorations:
- Direct and indirect composite resins
- Acrylic provisional crowns and bridges
- Acrylic appliances
- Glass ionomers and resin-modified glass ionomers
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063228 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063228: Surface Coat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063228
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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