510(k) · Cleared
ClearedPSL Biozir Block
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
P.S.L. International, Inc. · EIH Powder, Porcelain
Cleared on Feb 6, 2008 as substantially equivalent to K062695 (Sagemax Bioceramics, Inc., 2006) and 5 other predicates after a 48-day review. Its family tree reaches back 6 generations to 1983.
- Decided
- Feb 6, 2008
- Review
- 48 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K830955 (1983). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 5 generations backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- 4 generations backK984201 DenzirDentronic AB · 1999
- 3 generations backK023327 Cynovad ZirkonCynovad · 2002
- 2 generations backK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- 1 generation backK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
- This deviceK073568 PSL Biozir BlockP.S.L. International, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| −5 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| −4 | K984201 | Denzir | Dentronic AB | 1999 | — |
| −3 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| −2 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| −1 | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
| 0 (this device) | K073568 | PSL Biozir Block | P.S.L. International, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 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 EIH? 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 EIH device
- #1 K192231 Dental Glass Ceramics Blocksscore 15.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K062695 | Sagemax Z-BlankSummary page 1…uivalence: Relative to devices currently on the market, cleared by the 510(k) process, PSL International, Inc. is substantially equivalent to Sagemax Z-Blank, cleared in K062695, to Xavex cleared in K050903, to Medin Tech Zirconia CP10, 10 0 0 TM cleared in K043472, and to Cynovad Zirkon cleared in K023327… | 2006 |
| * | K050903 | Xawex G 100Summary page 1…s currently on the market, cleared by the 510(k) process, PSL International, Inc. is substantially equivalent to Sagemax Z-Blank, cleared in K062695, to Xavex cleared in K050903, to Medin Tech Zirconia CP10, 10 0 0 TM cleared in K043472, and to Cynovad Zirkon cleared in K023327 and equivalent to DenzirTMl… | 2005 |
| * | K043472 | Medin Tech Zirconia-CP10, SS1000Summary page 1…SL International, Inc. is substantially equivalent to Sagemax Z-Blank, cleared in K062695, to Xavex cleared in K050903, to Medin Tech Zirconia CP10, 10 0 0 TM cleared in K043472, and to Cynovad Zirkon cleared in K023327 and equivalent to DenzirTMl (Dentronic AB) cleared under K984201 as well as Cercon Base… | 2005 |
| * | K023327 | Cynovad ZirkonSummary page 1…uivalent to Sagemax Z-Blank, cleared in K062695, to Xavex cleared in K050903, to Medin Tech Zirconia CP10, 10 0 0 TM cleared in K043472, and to Cynovad Zirkon cleared in K023327 and equivalent to DenzirTMl (Dentronic AB) cleared under K984201 as well as Cercon BaseJm (Degussa Dental) cleared under K-013230… | 2002 |
| * | K984201 | DenzirSummary page 1…in K050903, to Medin Tech Zirconia CP10, 10 0 0 TM cleared in K043472, and to Cynovad Zirkon cleared in K023327 and equivalent to DenzirTMl (Dentronic AB) cleared under K984201 as well as Cercon BaseJm (Degussa Dental) cleared under K-013230. Like Sagemax Z-blank, it is intended to be marketed as a parti… | 1999 |
| * | K013230 | Cercon BaseSummary page 1…3472, and to Cynovad Zirkon cleared in K023327 and equivalent to DenzirTMl (Dentronic AB) cleared under K984201 as well as Cercon BaseJm (Degussa Dental) cleared under K-013230. Like Sagemax Z-blank, it is intended to be marketed as a partially sintered device which will then be machined and fully sinter… | 2001 |
| † | K001815 | DC Zirkon | 2000 |
| † | K950299 | CEREC 2 | 1995 |
| † | K972276 | Cerec 2 Crown Software | 1997 |
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 25 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- None of the 14 ancestors has a recall.
- 7 other devices also cite its predicate K062695.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · EIH
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIH
84in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIH
1in 2025
MAUDE reports naming product code EIH, 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 | 15 | 63 | 0 | 0 |
| 2008 | 15 | 87 | 0 | 1 |
| 2009 | 15 | 79 | 0 | 0 |
| 2010 | 14 | 89 | 0 | 0 |
| 2011 | 14 | 80 | 0 | 1 |
| 2012 | 9 | 96 | 0 | 0 |
| 2013 | 16 | 107 | 0 | 6 |
| 2014 | 18 | 118 | 0 | 1 |
| 2015 | 23 | 118 | 0 | 0 |
| 2016 | 22 | 187 | 21 | 4 |
| 2017 | 16 | 149 | 0 | 1 |
| 2018 | 10 | 139 | 0 | 2 |
| 2019 | 16 | 125 | 0 | 1 |
| 2020 | 13 | 155 | 0 | 0 |
| 2021 | 17 | 131 | 0 | 22 |
| 2022 | 16 | 89 | 0 | 0 |
| 2023 | 15 | 114 | 0 | 0 |
| 2024 | 28 | 89 | 0 | 7 |
| 2025 | 13 | 84 | 1 | 1 |
| 2026 | 14 | 73 | 0 | — |
What is it indicated for?
Intended for use in preparation of crowns, facings, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish. Frequently used with porcelain overlay for translucence and related effects. For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations.
Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073568 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073568: PSL Biozir Block.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073568
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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