510(k) · Cleared
ClearedParkell Self-Adhesive Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parkell, Inc. · EMA Cement, Dental
Cleared on Jan 20, 2022 as substantially equivalent to K073173 (Dentsply Interntional, 2008) after a 353-day review. Its family tree reaches back 5 generations to 1990. 1 later device descends from it.
- Decided
- Jan 20, 2022
- Review
- 353 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K900510 (1990). 11 ancestors in all, the oldest K873882 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK900510 Pertac-HybridEspe GmbH (Us) · 1990
- 4 generations backK962440 Pertac II/Pertac II AplitipEspe GmbH & Co. Kg. · 1996
- 3 generations backK974458 Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998
- 2 generations backK020256 Unicem3M Espe AG Dental Products · 2002
- 1 generation backK073173 Self-Adhesive Resin CementDentsply Interntional · 2008
- This deviceK210259 Parkell Self-Adhesive CementParkell, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK253337 REGEN Bioactive CementInter-Med, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253337REGEN Bioactive CementInter-Med, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K900510 | Pertac-Hybrid | Espe GmbH (Us) | 1990 | — |
| −4 | K962440 | Pertac II/Pertac II Aplitip | Espe GmbH & Co. Kg. | 1996 | — |
| −3 | K974458 | Compolute Aplicap | Espe Dental-Medizin GmbH & Co.Kg. | 1998 | — |
| −2 | K020256 | Unicem | 3M Espe AG Dental Products | 2002 | — |
| −1 | K073173 | Self-Adhesive Resin Cement | Dentsply Interntional | 2008 | — |
| 0 (this device) | K210259 | Parkell Self-Adhesive Cement | Parkell, Inc. | 2022 | — |
| +1 | K253337 | REGEN Bioactive Cement | Inter-Med, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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 K254109 G-Cem Universalscore 15.0 · 13 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 |
|---|---|---|---|
| * | K073173 | Self-Adhesive Resin CementSummary page 4…tion Number: 21 CFR 872.3275 Product Code: EMA Device Classification II 4. Primary Predicate Device Self-adhesive Cement (K073173, Dentsply International) (now marketed by Dentsply under the trade name “SmartCem2”). 5. Device Description Parkell Self-Adhesi… | 2008 |
| † | K190339 | Helioseal F Plus | 2019 |
| † | K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCP | 2018 |
| † | K161042 | CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle… | 2016 |
| † | K151518 | Brush&Bond Plus | 2015 |
| † | K190930 | SmarTemp X1 | 2019 |
| † | K182296 | HyperFil-LV | 2018 |
| † | K020946 | Adper Prompt | 2002 |
| † | K141081 | Filtek Bulk Fill Posterior Restroative | 2014 |
| † | K111185 | Relyx Luting Plus Automix | 2011 |
| † | K102984 | AURA | 2010 |
| † | K143209 | SonicFill 2 | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253337 | REGEN Bioactive Cement | 2026 | 0 |
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 32 years and passes through 6 companies; a new generation was cleared every 5.8 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K253337 (Inter-Med, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K073173.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · EMA
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EMA
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EMA
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMA
9in 2025
MAUDE reports naming product code EMA, 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 | 6 | 48 | 0 | 33 |
| 2008 | 13 | 71 | 2 | 50 |
| 2009 | 10 | 86 | 1 | 90 |
| 2010 | 14 | 86 | 1 | 106 |
| 2011 | 8 | 79 | 5 | 224 |
| 2012 | 10 | 128 | 0 | 249 |
| 2013 | 12 | 178 | 0 | 385 |
| 2014 | 4 | 174 | 0 | 207 |
| 2015 | 9 | 134 | 0 | 85 |
| 2016 | 10 | 182 | 0 | 16 |
| 2017 | 3 | 141 | 0 | 13 |
| 2018 | 3 | 237 | 0 | 4 |
| 2019 | 7 | 127 | 0 | 12 |
| 2020 | 8 | 164 | 0 | 5 |
| 2021 | 4 | 184 | 0 | 8 |
| 2022 | 7 | 245 | 0 | 3 |
| 2023 | 2 | — | 1 | 6 |
| 2024 | 3 | 59 | 0 | 5 |
| 2025 | 10 | 106 | 0 | 9 |
| 2026 | 7 | 150 | 0 | — |
What is it indicated for?
Parkell Self-Adhesive Cement is intended for the cementation of indirect restoratives including ceramic, zirconia, composite, and metal-based inlays, onlays, crowns, bridges, and posts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210259 · printed Nov 3, 2026
Cite this page
510(k) Report. “K210259: Parkell Self-Adhesive Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K210259
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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