510(k) Report

510(k) · Cleared

Cleared

Dental Lithium Disilicate Glass Ceramic Block (UP. Press Series and UP. Cad Series)

K141727510(k) TraditionalCleared Dec 18, 2014175-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

Liaoning Upcera Co., Ltd. · EIH Powder, Porcelain

Cleared on Dec 18, 2014 as substantially equivalent to K123952 (Sirona Dental Systems GmbH, 2013) after a 175-day review. Its family tree reaches back 2 generations to 2007. 8 later devices descend from it.

Decided
Dec 18, 2014
Review
175 days
Class
Class II
Product code
EIH
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K070772 (2007). 3 ancestors in all. 8 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2024: 3 descendants cleared2020: 1 descendant cleared2023: 4 descendants clearedK070772 · Pressx ZR · Wieland Dental + Technik GmbH & Co. KG · 2007K123952 · Cerec Blocs C in · Sirona Dental Systems GmbH · 201320052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 5 descendants K123952 · Cerec Blocs C in · Sirona Dental Systems GmbH · 2013K070772 · Pressx ZR · Wieland Dental + Technik GmbH & Co. KG · 20070
  1. Root · 2 generations backK070772 Pressx ZRWieland Dental + Technik GmbH & Co. KG · 2007
  2. 1 generation backK123952 Cerec Blocs C inSirona Dental Systems GmbH · 2013
  3. This deviceK141727 Dental Lithium Disilicate Glass Ceramic Block (UP. Press Series and…Liaoning Upcera Co., Ltd. · 2014
  4. Descendant · cites it directly · 5 of its ownK192231 Dental Glass Ceramics BlocksAidite (Qinhuangdao) Technology Co., Ltd. · 2020
  5. Descendant · 2 generations on · 0 of its ownK242407 Dental Glass Ceramics Blocks (HT, LT, MT)Hunan Vsmile Biotechnology Co., Ltd. · 2024
  6. Descendant · 2 generations on · 0 of its ownK241715 Dental Glass Ceramics Blocks (HT,LT,ST)Aidite (Qinhuangdao) Technology Co., Ltd. · 2024
  7. Descendant · cites it directly · 0 of its ownK232673 Dental Glass CeramicsChengdu Besmile Medical Technology Co., Ltd. · 2024
  8. Descendant · 2 generations on · 0 of its ownK232438 Dental Glass Ceramics BlocksAibodent Biotechnology Co., Ltd. · 2023

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2020: 12023: 42024: 3
2020high 4 (2023) · low 0 (2021)2026

Most influential descendants

Showing 5 of 8 · See all
  • K192231Dental Glass Ceramics BlocksAidite (Qinhuangdao) Technology Co., Ltd. · 2020 · cites it directly5descendants
  • K242407Dental Glass Ceramics Blocks (HT, LT, MT)Hunan Vsmile Biotechnology Co., Ltd. · 2024 · 2 generations on0descendants
  • K241715Dental Glass Ceramics Blocks (HT,LT,ST)Aidite (Qinhuangdao) Technology Co., Ltd. · 2024 · 2 generations on0descendants
  • K232673Dental Glass CeramicsChengdu Besmile Medical Technology Co., Ltd. · 2024 · cites it directly0descendants
  • K232438Dental Glass Ceramics BlocksAibodent Biotechnology Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K070772Pressx ZRWieland Dental + Technik GmbH & Co. KG2007—
−1K123952Cerec Blocs C inSirona Dental Systems GmbH2013—
0 (this device)K141727Dental Lithium Disilicate Glass Ceramic Block (UP. Press Series and UP. Cad…Liaoning Upcera Co., Ltd.2014—
+1K192231Dental Glass Ceramics BlocksAidite (Qinhuangdao) Technology Co., Ltd.2020—
+2K242407Dental Glass Ceramics Blocks (HT, LT, MT)Hunan Vsmile Biotechnology Co., Ltd.2024—
+2K241715Dental Glass Ceramics Blocks (HT,LT,ST)Aidite (Qinhuangdao) Technology Co., Ltd.2024—
+1K232673Dental Glass CeramicsChengdu Besmile Medical Technology Co., Ltd.2024—
+2K232438Dental Glass Ceramics BlocksAibodent Biotechnology Co., Ltd.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202340
202430
FIG. 1 — Lineage of K141727, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K123952Cerec Blocs C in
Summary page 4
…: II Regulation Number: 21 CFR 872.6660 Panel: General Dental Product Code: EIH 5.5 Predicate Device Information: (1) K123952, “CEREC Blocs C In”, manufactured by “Sirona Dental Systems GmbH” 5.6 Device description: Dental Lithium Disilicate Glass C…
Sirona Dental Systems GmbH2013—

What descends from it? (8)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K192231Dental Glass Ceramics BlocksAidite (Qinhuangdao) Technology Co., Ltd.20205
K232673Dental Glass CeramicsChengdu Besmile Medical Technology Co., Ltd.20240
K223194Glass CeramicShenzhen Xiangtong Co., Ltd.20230

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 7 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K192231 (Aidite (Qinhuangdao) Technology Co., Ltd., 2020) has gone furthest, with 5 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. 2014, 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?

Dental Lithium Disilicate Glass Ceramic Blocks (Up. Press Series and Up. CAD Series) are indicated for fabricating all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K141727: Dental Lithium Disilicate Glass Ceramic Block (UP. Press Series and UP. Cad Series).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141727

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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