510(k) · Cleared
ClearedPanavia F
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray America, Inc. · EMA Cement, Dental
Cleared on Nov 13, 1998 as substantially equivalent to K933030 (Kuraray Co., 1994) and 2 other predicates after a 50-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Nov 13, 1998
- Review
- 50 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K933030 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK933030 Panavia 21Kuraray Co. · 1994
- This deviceK983361 Panavia FKuraray America, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933030 | Panavia 21 | Kuraray Co. | 1994 | — |
| 0 (this device) | K983361 | Panavia F | Kuraray America, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 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 EMA? 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 EMA device
- #1 K254109 G-Cem Universalscore 15.0 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K933030 | Panavia 21Summary page 1…ary Name PANAVIAF 2) Classification Name Dental Cement (21 CFR 872.3275) 3) Common/Usual Name Dental Adhesive 4. Predicate devices: 1. PANAVIA 21 by Kuraray Co., Ltd. (K933030) 2. VARIOLINK II by Ivoclar North America Inc. (K971372) 3. C&B META BOND by Perkell (K960464) 5. Description for the premarket… | 1994 |
| * | K971372 | Variolink IISummary page 1…21 CFR 872.3275) 3) Common/Usual Name Dental Adhesive 4. Predicate devices: 1. PANAVIA 21 by Kuraray Co., Ltd. (K933030) 2. VARIOLINK II by Ivoclar North America Inc. (K971372) 3. C&B META BOND by Perkell (K960464) 5. Description for the premarket notification’ PANAVIA F is classified into dental cement… | 1997 |
| * | K960464 | C & B Metabond (Modification)Summary page 1…Dental Adhesive 4. Predicate devices: 1. PANAVIA 21 by Kuraray Co., Ltd. (K933030) 2. VARIOLINK II by Ivoclar North America Inc. (K971372) 3. C&B META BOND by Perkell (K960464) 5. Description for the premarket notification’ PANAVIA F is classified into dental cement, CFR 21 Section 872.3275, because it… | 1996 |
| † | K855211 | Panavia EX, a Dental Adhesive | 1986 |
| † | K974486 | Clearfil Liner Bond 2V | 1998 |
| † | K965091 | Teethmate F-1 | 1997 |
| † | K974089 | Alloy Primer | 1997 |
| † | K890494 | Fluorever Pit and Fissure Sealant or Fluorever PFS | 1989 |
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?
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K933030.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EMA
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EMA
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EMA
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMA
9in 2025
MAUDE reports naming product code EMA, 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 | 6 | 48 | 0 | 33 |
| 2008 | 13 | 71 | 2 | 50 |
| 2009 | 10 | 86 | 1 | 90 |
| 2010 | 14 | 86 | 1 | 106 |
| 2011 | 8 | 79 | 5 | 224 |
| 2012 | 10 | 128 | 0 | 249 |
| 2013 | 12 | 178 | 0 | 385 |
| 2014 | 4 | 174 | 0 | 207 |
| 2015 | 9 | 134 | 0 | 85 |
| 2016 | 10 | 182 | 0 | 16 |
| 2017 | 3 | 141 | 0 | 13 |
| 2018 | 3 | 237 | 0 | 4 |
| 2019 | 7 | 127 | 0 | 12 |
| 2020 | 8 | 164 | 0 | 5 |
| 2021 | 4 | 184 | 0 | 8 |
| 2022 | 7 | 245 | 0 | 3 |
| 2023 | 2 | — | 1 | 6 |
| 2024 | 3 | 59 | 0 | 5 |
| 2025 | 10 | 106 | 0 | 9 |
| 2026 | 7 | 150 | 0 | — |
What is it indicated for?
PANAVIA F is indicated for the following applications:
1) Cementation of metal crowns and bridges, inlays and onlays.
2) Cementation of porcelain crowns, inlays and onlays.
3) Cementation of to composite resin crowns, inlays and onlays
4) Cementation of adhesion bridges and splints
5) Cementation of metal cores and prefabrication posts
6) Bonded amalgam restorations
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983361 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983361: Panavia F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983361
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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