Home › Device types › EMA
Cement, Dental
FDA product code EMA · Class 2 · Dental
3,198
Registered devices
1,630
Adverse events
16
Recalls
508
510(k) clearances
Devices with this code
TheraCem Ca — BISCO INC.Vivid Core-Cem Liquid — PEARSON DENTAL SUPPLIES, INC.Improv Temporary Implant Cement by Salvin Dental Specialties — SCIENTIFIC PHARMACEUTICALS, INC.PANAVIA™ Veneer LC — KURARAY NORITAKE DENTAL INC.G-CEM One — Gc America Inc.NanoPaq C 2, 4 g — Schütz Dental GmbHiCEM Universal Plus — SUN MEDICAL CO.,LTD.RIVA LC — SDI LIMITEDHarvard Cement quick setting, Single powder, Shade 4 — Harvard Dental International GmbHSet — SDI LIMITEDAnchor 25ml Cartridge Kit Shade White Opaque — Vista DentalGlasIonomer FX ULTRA — SHOFU DENTAL CORPORATIONAHfil+ — ADVANCED HEALTHCARE LTD.COE-PAK™ — Gc America Inc.AELITE- Aesthetic Univ Syr Kit — BISCO INC.DENTURE BASE — AMERICAN TOOTH INDUSTRIESNOGENOL™ — Gc America Inc.Provicol QM Aesthetic — VOCO GmbHIQ Dental — IQ DENTAL SUPPLY LLCKETAC™ — 3M COMPANYHenry Schein — HENRY SCHEIN, INC.RIVA LC — SDI LIMITEDPANAVIA™ SA Cement Plus Automix — KURARAY NORITAKE DENTAL INC.Calibra® Universal+ Versatile Resin Cement — DENTSPLY INTERNATIONAL 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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