510(k) · Cleared
ClearedCojet System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe GmbH & Co. Kg. · EBF Material, Tooth Shade, Resin
Cleared on Nov 27, 1996 as substantially equivalent to K902836 (Danville Engineering, Inc., 1990) after a 71-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Nov 27, 1996
- Review
- 71 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902836 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK902836 MicroetcherDanville Engineering, Inc. · 1990
- This deviceK963735 Cojet SystemEspe GmbH & Co. Kg. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902836 | Microetcher | Danville Engineering, Inc. | 1990 | — |
| 0 (this device) | K963735 | Cojet System | Espe GmbH & Co. Kg. | 1996 | — |
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 EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K902836 | MicroetcherSummary page 2…911061). CoJet™-Sand also is WAD1A/65040. 1 -2 - substantially equivalent to the aluminum oxide material used in the Microetcher™ Dental Bonding System (K902836/A). The silane coupling agent in the System is ESPE’s 510(k)- cleared ESPE®-SIL (K913965), and the bonding material is ESPE’s 510… | 1990 |
| † | K913857 | Rocatec (R) -Plus | 1991 |
| † | K925027 | Photac-Fil Aplicap | 1993 |
| † | K960547 | Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive | 1996 |
| † | K900510 | Pertac-Hybrid | 1990 |
| † | K913966 | Sono (R) -Cem | 1992 |
| † | K911061 | Espe Ketac-Endo Aplicap | 1992 |
| † | K913965 | Espe (R) -Sil | 1991 |
| † | K790833 | Visio-Bond | 1979 |
| † | K833757 | Visio-Gem | 1984 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K902836.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
ESPE is submitting a 510(k) premarket notification for its 4-component system for intraoral adhesive repair of porcelain and composite restorations and pretreatment for adhesive cementation, trade named CoJet™-System. The CoJet™-System’s intraoral adhesive restoration repair and adhesive cementation uses include: - adhesive repair of defects in porcelain - adhesive repair of defects in porcelain with exposed metal - adhesive repair of defects in…
Read the full statement (108 words)
ESPE is submitting a 510(k) premarket notification for its 4-component system for intraoral adhesive repair of porcelain and composite restorations and pretreatment for adhesive cementation, trade named CoJet™-System. The CoJet™-System’s intraoral adhesive restoration repair and adhesive cementation uses include:
- adhesive repair of defects in porcelain
- adhesive repair of defects in porcelain with exposed metal
- adhesive repair of defects in composite
- adhesive repair of defects in composite with exposed metal
- conditioning of metal restorations prior to cementation, e.g., crowns, bridges, inlays, onlays, root posts, core posts, etc.
- conditioning of porcelain or composite restorations prior to adhesive cementation, e.g., inlays, onlays, laminate veneers, etc.
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/K963735 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963735: Cojet System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963735
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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