Home › Device types › EMA
Cement, Dental
FDA product code EMA · Class 2 · Dental
3,218
Registered devices
1,630
Adverse events
16
Recalls
509
510(k) clearances
Devices with this code
Everest — Ortho Organizers, Inc.Henry Schein — HENRY SCHEIN, INC.PermaShade LC — ULTRADENT PRODUCTS, INC.Glass-FX Clear — D.S.I DENTAL SOLUTIONS LTDGlasIonomer F — SHOFU DENTAL CORPORATIONGlasIonomer FX-LC — SHOFU DENTAL CORPORATIONGC Fuji I® — Gc America Inc.NuSmile NuCem — NUSMILE, LTD.IonoStar Molar — VOCO GmbHCalibra® Universal+ Versatile Resin Cement — DENTSPLY INTERNATIONAL INC.EMBRACE WETBOND RESIN CEMENT — PULPDENT CORPORATIONRIVA SC — SDI LIMITEDNuSmile BioCem Medium Shade — NUSMILE, LTD.TopCEM Dual Cure Resin Cement — Rizhao HuGe Biomaterials Company, Ltd.Ketac™ Fil Plus Aplicap™ — 3M Deutschland GmbHCHEMFIL ROCK — Dentsply De Trey GmbHSet PP — SDI LIMITEDCalibra® Universal Self-Adhesive Resin Cement — DENTSPLY INTERNATIONAL INC.COLTOSOL F — Coltène/Whaledent AGBandtite Band Cement — AMERICAN ORTHODONTICS CORPORATIONSmartCem®2 Self-Adhesive Cement — DENTSPLY INTERNATIONAL INC.Harvard Polycarboxylat Cement, Clinic powder, Shade 4 — Harvard Dental International GmbHGC Fuji II LC® — Gc America Inc.TheraBase Ca — BISCO INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-25 | Voco GmbH | Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the corre |
| 2024-01-25 | Voco GmbH | Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the corre |
| 2023-10-04 | Family Dollar Stores, Llc. | Products were stored outside of labeled temperature requirements. |
| 2023-02-01 | Preat Corp | Product is labeled with an incorrect expiration date. |
| 2022-06-23 | Family Dollar Stores, Llc. | Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022. |
| 2020-02-25 | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical | An issue within production process used to package trial kits let to the inclusion of the incorrect bonding agent for the kit. Use of the incorrect bonding age |
| 2011-11-10 | Henry Schein, Inc. | The specific lots of Maxcem Elite Refill Kit appear not to be authentic. |
| 2011-07-08 | Kerr/pentron Dba Kerr Corporation And Pentron Clinical | Pentron is voluntarily recalling the Breeze Self Adhesive Resin Cement because it was discovered that there may be a curing problem that may cause cemented crow |
| 2011-03-17 | Kerr/pentron Dba Kerr Corporation And Pentron Clinical | The firm initiated a recall because the product sets faster than specified in the "Directions for Use" and in release specifications. |
| 2011-03-03 | Kerr Corporation | The recall was initiated because Pentron Clinical has confirmed that the TempSpan Temporary Cement may have black plastic material on the surface of the paste, |
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