510(k) Report

510(k) · Cleared

Cleared

Cerec Blocs C in

K123952510(k) TraditionalCleared Mar 20, 201389-day reviewClass II21 CFR 872.6660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sirona Dental Systems GmbH · EIH Powder, Porcelain

Cleared on Mar 20, 2013 as substantially equivalent to K090644 (Vita Zahnfabrik H.Rauter GmbH & Co., 2009) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 2007. 9 later devices descend from it.

Decided
Mar 20, 2013
Review
89 days
Class
Class II
Product code
EIH
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K070772 (2007). 2 ancestors in all. 9 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2014: 1 descendant cleared2024: 3 descendants cleared2020: 1 descendant cleared2023: 4 descendants clearedK070772 · Pressx ZR · Wieland Dental + Technik GmbH & Co. KG · 200720052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 5 descendants K070772 · Pressx ZR · Wieland Dental + Technik GmbH & Co. KG · 20070
  1. Root · 1 generation backK070772 Pressx ZRWieland Dental + Technik GmbH & Co. KG · 2007
  2. This deviceK123952 Cerec Blocs C inSirona Dental Systems GmbH · 2013
  3. Descendant · cites it directly · 8 of its ownK141727 Dental Lithium Disilicate Glass Ceramic Block (UP. Press Series and…Liaoning Upcera Co., Ltd. · 2014
  4. Descendant · 2 generations on · 5 of its ownK192231 Dental Glass Ceramics BlocksAidite (Qinhuangdao) Technology Co., Ltd. · 2020
  5. Descendant · 3 generations on · 0 of its ownK242407 Dental Glass Ceramics Blocks (HT, LT, MT)Hunan Vsmile Biotechnology Co., Ltd. · 2024
  6. Descendant · 3 generations on · 0 of its ownK241715 Dental Glass Ceramics Blocks (HT,LT,ST)Aidite (Qinhuangdao) Technology Co., Ltd. · 2024
  7. Descendant · 2 generations on · 0 of its ownK232673 Dental Glass CeramicsChengdu Besmile Medical Technology Co., Ltd. · 2024

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2014: 12020: 12023: 42024: 3
2014high 4 (2023) · low 0 (2015)2026

Most influential descendants

Showing 5 of 9 · See all
  • K141727Dental Lithium Disilicate Glass Ceramic Block (UP. Press Series and UP. Cad Series)Liaoning Upcera Co., Ltd. · 2014 · cites it directly8descendants
  • K192231Dental Glass Ceramics BlocksAidite (Qinhuangdao) Technology Co., Ltd. · 2020 · 2 generations on5descendants
  • K242407Dental Glass Ceramics Blocks (HT, LT, MT)Hunan Vsmile Biotechnology Co., Ltd. · 2024 · 3 generations on0descendants
  • K241715Dental Glass Ceramics Blocks (HT,LT,ST)Aidite (Qinhuangdao) Technology Co., Ltd. · 2024 · 3 generations on0descendants
  • K232673Dental Glass CeramicsChengdu Besmile Medical Technology Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K070772Pressx ZRWieland Dental + Technik GmbH & Co. KG2007—
0 (this device)K123952Cerec Blocs C inSirona Dental Systems GmbH2013—
+1K141727Dental Lithium Disilicate Glass Ceramic Block (UP. Press Series and UP. Cad…Liaoning Upcera Co., Ltd.2014—
+2K192231Dental Glass Ceramics BlocksAidite (Qinhuangdao) Technology Co., Ltd.2020—
+3K242407Dental Glass Ceramics Blocks (HT, LT, MT)Hunan Vsmile Biotechnology Co., Ltd.2024—
+3K241715Dental Glass Ceramics Blocks (HT,LT,ST)Aidite (Qinhuangdao) Technology Co., Ltd.2024—
+2K232673Dental Glass CeramicsChengdu Besmile Medical Technology Co., Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
202010
202340
202430
FIG. 1 — Lineage of K123952, 2007–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K192231 Dental Glass Ceramics Blocksscore 15.2 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K090644Vitablocs, Model VX55-****
Summary page 1
…ication Name: Porcelain powder for clinical use 3 Device Classification 21 CFR 872.6660, Product Code EIH 4 Predicate Devices Vita's Vitablocs®&(K090644) and Wieland Dental + Technik's Press X Zr (K070772) Sirona Dental 5 10O(k) Summary December 20, 2012…
Vita Zahnfabrik H.Rauter GmbH & Co.2009—
*K070772Pressx ZR
Summary page 1
…3 Device Classification 21 CFR 872.6660, Product Code EIH 4 Predicate Devices Vita's Vitablocs®&(K090644) and Wieland Dental + Technik's Press X Zr (K070772) Sirona Dental 5 10O(k) Summary December 20, 2012 Page 1 of 4 CEREC Blocs C In…
Wieland Dental + Technik GmbH & Co. KG2007—

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K141727Dental Lithium Disilicate Glass Ceramic Block (UP. Press Series and UP. Cad Series)Liaoning Upcera Co., Ltd.20148

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 2 ancestors has a recall.
  • Of its descendants, K141727 (Liaoning Upcera Co., Ltd., 2014) has gone furthest, with 8 descendants of its own.

How does its category compare?

All EIH devices

EIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · EIH

13in 2025

2007: 152008: 152009: 152010: 142011: 142012: 92013: 162014: 182015: 232016: 222017: 162018: 102019: 162020: 132021: 172022: 162023: 152024: 282025: 132026 (partial year): 14
2007high 28 (2024) · low 9 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EIH

84in 2025

2007: 63 days median2008: 87 days median2009: 79 days median2010: 89 days median2011: 80 days median2012: 96 days median2013: 107 days median2014: 118 days median2015: 118 days median2016: 187 days median2017: 149 days median2018: 139 days median2019: 125 days median2020: 155 days median2021: 131 days median2022: 89 days median2023: 114 days median2024: 89 days median2025: 84 days median2026 (partial year): 73 days median
2007high 187 (2016) · low 63 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EIH

1in 2025

2016: 212025: 1
2007high 21 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EIH

1in 2025

2008: 12011: 12013: 62014: 12016: 42017: 12018: 22019: 12021: 222024: 72025: 1
2007high 22 (2021) · low 0 (2007)2025

MAUDE reports naming product code EIH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007156300
2008158701
2009157900
2010148900
2011148001
201299600
20131610706
20141811801
20152311800
201622187214
20171614901
20181013902
20191612501
20201315500
202117131022
2022168900
20231511400
2024288907
2025138411
202614730—

What is it indicated for?

CEREC blocs C In are indicated for the fabrication of veneers and of crowns in anterior teeth and in premolars that have not been endodontically treated, using the Sirona CAD/CAM system.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K123952: Cerec Blocs C in.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123952

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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