510(k) Report

510(k) · Cleared

Cleared

Integrity Temporary Cement

K040895510(k) TraditionalCleared May 21, 200445-day reviewClass II21 CFR 872.3275

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

Dentsply Intl. · EMA Cement, Dental

Cleared on May 21, 2004 as substantially equivalent to K853431 (Dentsply Intl., 1985) and 1 other predicate after a 45-day review. Its family tree reaches back 1 generation to 1985.

Decided
May 21, 2004
Review
45 days
Class
Class II
Product code
EMA
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K853431 (1985). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1985: 1 other ancestorK853431 · Dental Cement · Dentsply Intl. · 198519851990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K853431 · Dental Cement · Dentsply Intl. · 19850
  1. Root · 1 generation backK853431 Dental CementDentsply Intl. · 1985
  2. This deviceK040895 Integrity Temporary CementDentsply Intl. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K853431Dental CementDentsply Intl.1985—
0 (this device)K040895Integrity Temporary CementDentsply Intl.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
FIG. 1 — Lineage of K040895, 1985–2004Source: 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 EMA? 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 EMA device

  1. #1 K254109 G-Cem Universalscore 15.0 · 13 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
*K853431Dental Cement
Summary page 1
…TEMPORARY CEMENT CLASSIFICATION NAME: Dental cement (872.3275) PREDICATE DEVICES: BIOMER TM Composite Luting Cement (K853431) T.E.R.M. TM VLC Temporary Endo Restorative Material (K854253) DEVICE DESCRIPTION: INTEGRITY…
Dentsply Intl.1985—
*K854253Root Canal Filling Resin
Summary page 1
…) PREDICATE DEVICES: BIOMER TM Composite Luting Cement (K853431) T.E.R.M. TM VLC Temporary Endo Restorative Material (K854253) DEVICE DESCRIPTION: INTEGRITY TM TEMPORARY CEMENT is a dual-cured or self- cured temporary resin cement for use with provision…
Dentsply Intl.1985—

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?

  • None of the 2 ancestors has a recall.

How does its category compare?

All EMA devices

EMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EMA

10in 2025

2007: 62008: 132009: 102010: 142011: 82012: 102013: 122014: 42015: 92016: 102017: 32018: 32019: 72020: 82021: 42022: 72023: 22024: 32025: 102026 (partial year): 7
2007high 14 (2010) · low 2 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EMA

106in 2025

2007: 48 days median2008: 71 days median2009: 86 days median2010: 86 days median2011: 79 days median2012: 128 days median2013: 178 days median2014: 174 days median2015: 134 days median2016: 182 days median2017: 141 days median2018: 237 days median2019: 127 days median2020: 164 days median2021: 184 days median2022: 245 days median2024: 59 days median2025: 106 days median2026 (partial year): 150 days median
2007high 245 (2022) · low 48 (2007)2026

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

Recalls per year · EMA

1in 2023

2008: 22009: 12010: 12011: 52023: 1
2007high 5 (2011) · low 0 (2007)2026

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

Adverse event reports per year · EMA

9in 2025

2007: 332008: 502009: 902010: 1062011: 2242012: 2492013: 3852014: 2072015: 852016: 162017: 132018: 42019: 122020: 52021: 82022: 32023: 62024: 52025: 9
2007high 385 (2013) · low 3 (2022)2025

MAUDE reports naming product code EMA, 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
2007648033
20081371250
20091086190
201014861106
20118795224
2012101280249
2013121780385
201441740207
20159134085
201610182016
20173141013
2018323704
20197127012
2020816405
2021418408
2022724503
20232—16
202435905
20251010609
202671500—

What is it indicated for?

INTEGRITY TM TEMPORARY CEMENT is indicated for:

I. Temporary cementation of provisional acrylic and composite indirect restorations to prepared teeth or implant abutments.

2. Provisional or trial cementation of ceramic, porcelain, composite, PFM (porcelain fused to metal) and all metal crowns and bridges to prepared teeth or implant abutments.

3. Cementation of ceramic, porcelain, composite, PFM (porcelain fused to metal) and all metal crowns and bridges to implant abutments and telescopic fixed restorations which require periodic removal for maintenance., etc.

Indications for use as stated in the FDA summary.

More from Dentsply Intl.

279 FDA decisions under this applicant name. See the company

  • K123615Iris - High Strength Glass CeramicDentsply Intl. · 2013
  • K072730Friadent Cercon and Ankylos Cercon Balance AbutmentsDentsply Intl. · 2008
  • K070538XP Bond Dual Cure Universal Total Etch AdhesiveDentsply Intl. · 2007
  • K070019Carrara VolumiaDentsply Intl. · 2007
  • K061427Pre-Impression Conditioning SolutionDentsply Intl. · 2006

Recent decisions in EMA

The EMA category page

  • K262983EsTemp ImplantSpident Co., Ltd. · 2026
  • K254201Any-CemMediclus Co., Ltd. · 2026
  • K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak · 2026
  • K261166Dia-CemDiaDent Group International · 2026
  • K254109G-Cem UniversalGC America, Inc. · 2026

https://510kreport.com/device/K040895 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040895: Integrity Temporary Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040895

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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