510(k) · Cleared
ClearedDoc's Best White Copper Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cooley & Cooley, Ltd. · EMA Cement, Dental
Cleared on Nov 12, 2003 as substantially equivalent to K933139 (3M Company, 1994) and 3 other predicates after a 183-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Nov 12, 2003
- Review
- 183 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K900510 (1990). 13 ancestors in all, the oldest K873882 (1988). No later device cites it as a predicate yet.
- 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 deviceK031494 Doc's Best White Copper CementCooley & Cooley, Ltd. · 2003
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) | K031494 | Doc's Best White Copper Cement | Cooley & Cooley, Ltd. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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? (5)
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 |
|---|---|---|---|
| * | K933139 | 3M Vitremer Luting CementSummary page 1…commercial distribution prior to the Medical Device Amendments issued May 28, 1976. The other predicate devices include the 3M Vitremer Luting Cement (K933139), 3M RelyX Luting Cement (K022476), 3M ESPE UNTCEM (K020256) and Dentsply Intl Temporary Dental Cement (K895487). These de… | 1994 |
| * | K022476 | Relyx RmgipSummary page 1…to the Medical Device Amendments issued May 28, 1976. The other predicate devices include the 3M Vitremer Luting Cement (K933139), 3M RelyX Luting Cement (K022476), 3M ESPE UNTCEM (K020256) and Dentsply Intl Temporary Dental Cement (K895487). These devices were cleared for intr… | 2002 |
| * | K020256 | UnicemSummary page 1…ndments issued May 28, 1976. The other predicate devices include the 3M Vitremer Luting Cement (K933139), 3M RelyX Luting Cement (K022476), 3M ESPE UNTCEM (K020256) and Dentsply Intl Temporary Dental Cement (K895487). These devices were cleared for introduction into interstate c… | 2002 |
| * | K895487 | Temporary Dental CementSummary page 1…ices include the 3M Vitremer Luting Cement (K933139), 3M RelyX Luting Cement (K022476), 3M ESPE UNTCEM (K020256) and Dentsply Intl Temporary Dental Cement (K895487). These devices were cleared for introduction into interstate commerce via the FDA's 510(k) Notification process. T… | 1990 |
| * | — | Doc's Best Red Copper Cement Named without a submission number |
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?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- None of the 13 ancestors has a recall.
- 3 other devices also cite its predicate K933139.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Doc's Best White Copper Cement is a dental cement system for use in:
1. Luting porcelain to metal crowns and bridges to tooth structure, amalgam, composite or glass isomer core building;
2. Luting metal inlays, on lays or crowns;
3. Luting pre-fabricated and cast posts;
4. Luting orthodontic appliances;
5. Cavity liners;
6. Primary teeth cavity fillings
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031494: Doc's Best White Copper Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031494
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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