510(k) · Cleared
ClearedDLMS-Zirblocks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dental Milling Laboratory Supplies (Dlms) · EIH Powder, Porcelain
Cleared on Feb 10, 2009 as substantially equivalent to K072569 (Metoxit AG, 2007) after a 196-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Feb 10, 2009
- Review
- 196 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K013230 (2001). 9 ancestors in all, the oldest K001815 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK013230 Cercon BaseDegussa - Ney Dental, Inc. · 2001
- 2 generations backK050903 Xawex G 100Wieland Dental + Technik GmbH & Co. KG · 2005
- 1 generation backK072569 Metoxit Cam-BlanksMetoxit AG · 2007
- This deviceK082137 DLMS-ZirblocksDental Milling Laboratory Supplies (Dlms) · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013230 | Cercon Base | Degussa - Ney Dental, Inc. | 2001 | — |
| −2 | K050903 | Xawex G 100 | Wieland Dental + Technik GmbH & Co. KG | 2005 | — |
| −1 | K072569 | Metoxit Cam-Blanks | Metoxit AG | 2007 | — |
| 0 (this device) | K082137 | DLMS-Zirblocks | Dental Milling Laboratory Supplies (Dlms) | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 3 | 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 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? (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 |
|---|---|---|---|
| * | K072569 | Metoxit Cam-BlanksSummary page 1…Name CAM-Blanks Predicate Devices Legally marketed device to which we claim equivalence: Metoxit CAM-Blanks, Metoxit AG, K072569 Description DLMS-Zirblocks is a partially sintered yttria (yttrium oxide) stabilized zirc… | 2007 |
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 8 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 5 other devices also cite its predicate K072569.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 CAD/CAM technology to produce copings, bridges, and framework core material usage for fixed prosthodontics. Then veneered with porcelain glass to create final restoration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082137: DLMS-Zirblocks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082137
Report an extraction error
Are you the manufacturer?
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