510(k) · Cleared
ClearedSelf-Adhesive Resin Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Interntional · EMA Cement, Dental
Cleared on Jan 23, 2008 as substantially equivalent to K020256 (3M Espe AG Dental Products, 2002) and 1 other predicate after a 71-day review. Its family tree reaches back 4 generations to 1990. 6 later devices descend from it.
- Decided
- Jan 23, 2008
- Review
- 71 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K900510 (1990). 10 ancestors in all, the oldest K873882 (1988). 6 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK900510 Pertac-HybridEspe GmbH (Us) · 1990
- 3 generations backK962440 Pertac II/Pertac II AplitipEspe GmbH & Co. Kg. · 1996
- 2 generations backK974458 Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998
- 1 generation backK020256 Unicem3M Espe AG Dental Products · 2002
- This deviceK073173 Self-Adhesive Resin CementDentsply Interntional · 2008
- Descendant · cites it directly · 3 of its ownK081913 Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK210259 Parkell Self-Adhesive CementParkell, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK171449 MetacemMeta Biomed Co., Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK261166 Dia-CemDiaDent Group International · 2026
- Descendant · 2 generations on · 0 of its ownK253337 REGEN Bioactive CementInter-Med, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008 · cites it directly3descendants
- K210259Parkell Self-Adhesive CementParkell, Inc. · 2022 · cites it directly1descendant
- K171449MetacemMeta Biomed Co., Ltd. · 2018 · 2 generations on1descendant
- K261166Dia-CemDiaDent Group International · 2026 · 3 generations on0descendants
- K253337REGEN Bioactive CementInter-Med, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K900510 | Pertac-Hybrid | Espe GmbH (Us) | 1990 | — |
| −3 | K962440 | Pertac II/Pertac II Aplitip | Espe GmbH & Co. Kg. | 1996 | — |
| −2 | K974458 | Compolute Aplicap | Espe Dental-Medizin GmbH & Co.Kg. | 1998 | — |
| −1 | K020256 | Unicem | 3M Espe AG Dental Products | 2002 | — |
| 0 (this device) | K073173 | Self-Adhesive Resin Cement | Dentsply Interntional | 2008 | — |
| +1 | K081913 | Metacem, Meta P&Bond, Metacem Silane Ceramic Primer | Meta Biomed Co., Ltd. | 2008 | — |
| +1 | K210259 | Parkell Self-Adhesive Cement | Parkell, Inc. | 2022 | — |
| +2 | K171449 | Metacem | Meta Biomed Co., Ltd. | 2018 | — |
| +3 | K261166 | Dia-Cem | DiaDent Group International | 2026 | — |
| +2 | 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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2026 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020256 | UnicemSummary page 1…IETARY NAME: Self-adhesive Cement CLASSIFICATION NAME: Dental cement, 21 CFR 872.3275 PREDICATE DEVICES: Unicem, K020256 and MaxCem, K041474 DEVICE DESCRIPTION: Self-adhesive Resin C(:ment consists of a base paste and a catalyst paste, mixed to for… | 2002 |
| * | K041474 | MaxcemSummary page 1…Self-adhesive Cement CLASSIFICATION NAME: Dental cement, 21 CFR 872.3275 PREDICATE DEVICES: Unicem, K020256 and MaxCem, K041474 DEVICE DESCRIPTION: Self-adhesive Resin C(:ment consists of a base paste and a catalyst paste, mixed to form a dual-curing ceme… | 2004 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 5 companies; a new generation was cleared every 5.8 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K081913 (Meta Biomed Co., Ltd., 2008) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K020256.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Self-adhesive Resin Cement is intended for the cementation of indirect restoratives including ceramic, composite and metal-based inlays, onlays, crowns, bridges, and posts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073173 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073173: Self-Adhesive Resin Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073173
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