510(k) · Cleared
ClearedCeramic Pedatric Preformed Crown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ez-Pedo, Inc. · ELZ Crown, Preformed
Cleared on Jun 29, 2009 as substantially equivalent to K931162 (King Dental Corp., 1993) and 2 other predicates after a 52-day review. Its family tree reaches back 7 generations to 1983.
- Decided
- Jun 29, 2009
- Review
- 52 days
- Class
- Class I
- Product code
- ELZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K830955 (1983). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 6 generations backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- 5 generations backK984201 DenzirDentronic AB · 1999
- 4 generations backK023327 Cynovad ZirkonCynovad · 2002
- 3 generations backK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- 2 generations backK070045 Zirblank-PS and Zirblank-FSAcucera, Inc. · 2007
- 1 generation backK081253 Zirdent Cad/Cam BlocksC5 Medical Werks, Inc. · 2008
- This deviceK091362 Ceramic Pedatric Preformed CrownEz-Pedo, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| −6 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| −5 | K984201 | Denzir | Dentronic AB | 1999 | — |
| −4 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| −3 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| −2 | K070045 | Zirblank-PS and Zirblank-FS | Acucera, Inc. | 2007 | — |
| −1 | K081253 | Zirdent Cad/Cam Blocks | C5 Medical Werks, Inc. | 2008 | — |
| 0 (this device) | K091362 | Ceramic Pedatric Preformed Crown | Ez-Pedo, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 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 ELZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K931162 | King-Hue, Royal Coral, Super-C Artificial TeethSummary page 1…tric Preformed Crown is claimed to be substantially equivalent to the following legally marketed predicate devices: 1. King Dental Corporation Artificial Teeth (Class I, K931162) 2. NuSmile Preformed Crowns - Primary Crowns (Class I, 510(k) exempt) 3. Procera Bridge Zirconia (K041283) 4. C5 Medical Werks Z… | 1993 |
| * | K041283 | Procera Bridge ZirconiaSummary page 1…devices: 1. King Dental Corporation Artificial Teeth (Class I, K931162) 2. NuSmile Preformed Crowns - Primary Crowns (Class I, 510(k) exempt) 3. Procera Bridge Zirconia (K041283) 4. C5 Medical Werks ZirDent CAD/CAM Blocks (K081253) General Description: The EPI Ceramic Pediatric Preformed Crown is a tempor… | 2004 |
| * | K081253 | Zirdent Cad/Cam BlocksSummary page 1…(Class I, K931162) 2. NuSmile Preformed Crowns - Primary Crowns (Class I, 510(k) exempt) 3. Procera Bridge Zirconia (K041283) 4. C5 Medical Werks ZirDent CAD/CAM Blocks (K081253) General Description: The EPI Ceramic Pediatric Preformed Crown is a temporary tooth restoration. The dental crown is a tooth-s… | 2008 |
| * | — | NuSmile Preformed Crowns - Primary Crowns Named without a submission number |
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 26 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- None of the 23 ancestors has a recall.
- 1 other device also cites its predicate K931162.
How does its category compare?
All ELZ devicesELZ Crown, Preformed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ELZ
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · ELZ
Too few ELZ 510(k)s in any year since 2007 to give a median.
Recalls per year · ELZ
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELZ
2in 2023
MAUDE reports naming product code ELZ, 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 | 0 | — | 1 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EZ-Pedo Inc. Ceramic Pediatric Preformed Crown is intended to be used as a functional restoration for primary teeth, including for a badly decayed deciduous (baby) tooth, until the adult tooth erupts. It is not intended for permanent restoration. The EZ-Pedo Inc. Ceramic Pediatric Preformed Crown is indicated for use in infants, children, and adolescents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091362 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091362: Ceramic Pedatric Preformed Crown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091362
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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