Cement, Dental
Dental · 21 CFR 872.3275
Recent MDR events
1,630 adverse event reports on file
- HENRY SCHEINJul 16, 2026MalfunctionParkell, Inc.2411797-2026-00004
- POLY F INTRO 70G/40MLJun 29, 2026InjuryDentsply Detrey Gmbh8010638-2026-00018
- PROVICOLMay 29, 2026InjuryVoco Gmbh8010908-2026-00003
- 3M¿ KETAC¿ CEM PLUS AUTOMIXMay 28, 2026Injury3m Espe Dental Products3005174370-2026-00001
- POLY F INTRO 70G/40MLApr 8, 2026MalfunctionDentsply Detrey Gmbh8010638-2026-00013
- 3M¿ RELYX¿ UNICEM 2 AUTOMIX SELF-ADHESIVE RESIN CEMENTDec 30, 2025Injury3m Deutschland Gmbh3008512935-2025-00006
- 3M¿ RELYX¿ LUTING PLUS AUTOMIX CEMENTNov 21, 2025Injury3m Espe Dental Products3005174370-2025-00004
- GLASS IONOMER CEMENTSep 3, 2025Injury3m Espe Dental ProductsMW5175561
- FLECK'S DENTAL CEMENTJun 20, 2025InjuryKeystone Industries3010002722-2025-00001
- NEXTEMPMay 21, 2025InjuryPremier Dental Products Company2511556-2025-00002
Event type breakdown
Recalls
16 recall events for this product code
- Voco GmbHOpen, ClassifiedFeb 16, 2024
IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
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 correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.
Z-1142-2024 · View FDA record ↗ - Voco GmbHOpen, ClassifiedFeb 16, 2024
Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
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 correct reactive component for Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.
Z-1143-2024 · View FDA record ↗ - Family Dollar Stores, Llc.Open, ClassifiedNov 7, 2023
DENTEMP ONE STEP .077OZ, SKU 902139
Products were stored outside of labeled temperature requirements.
Z-0265-2024 · View FDA record ↗ - Preat CorpOpen, ClassifiedMar 6, 2023
PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
Product is labeled with an incorrect expiration date.
Z-1226-2023 · View FDA record ↗ - Family Dollar Stores, Llc.Open, ClassifiedAug 17, 2022
DENTEMP ONE STEP .077OZ, SKU 902139
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Z-1529-2022 · View FDA record ↗ - Kerr CorporationTerminatedMar 14, 2012
Brand Name: TempSpan CMT Temporary Cement, a temporary cement.
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, and it may set faster than specified.
Z-1205-2012 · View FDA record ↗ - Kerr CorporationTerminatedFeb 24, 2012
Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation of porcelain, resin, and metal-based inlays, onlays, crowns, bridges,
The recall was initiated because Pentron Clinical has confirmed that the Breeze Self-Adhesive Resin Cement exhibits faster than expected gel and set times. If the work time is exceeded when using this material, it could possibly result in inadequate bond strength.
Z-1100-2012 · View FDA record ↗ - Henry Schein, Inc.TerminatedJan 11, 2012
Maxcem Elite(TM) self-etch/self-adhesive resin cement, Refill Kit, net wt. 10 g, REF/Part # 33872, CLEAR --- Refill Kit Contents: 2 Syringes (5 g ea), 10 Autom
The specific lots of Maxcem Elite Refill Kit appear not to be authentic.
Z-0390-2012 · View FDA record ↗ - Kerr/pentron Dba Kerr Corporation And Pentron ClinicalTerminatedJan 11, 2012
Dental cement under the brand name Cement-It and Natural Elegance (private label of Cement-It).
The firm initiated a recall because the product sets faster than specified in the "Directions for Use" and in release specifications.
Z-0454-2012 · View FDA record ↗ - Kerr CorporationTerminatedJan 11, 2012
Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product Description and Intended Use: The intended use of this device is for internal
The resin material separates when the product is extruded from the syringe. Although there are no safety issues related with this situation, please refrain from using the affected product.
Z-0455-2012 · View FDA record ↗
Registered firms
813 firms currently registered for this product code
Coltene/whaledent Ag
ALTSTAETTEN Sankt Gallen, CH
S & C Polymer Gmbh
ELMSHORN Schleswig-Holstein, DE
Gc Corporation-fuji Oyama Factory
SUNTO-GUN, Shizuoka-Ken, JP
Solventum Us Llc
Irvine, CA, US
Sun Medical Co., Ltd.
Moriyama Shiga, JP
Titanlinks Logistics Llc
Newark, DE, US
Ivoclar Vivadent, Inc.
AMHERST, NY, US
Gc America Inc.
ALSIP, IL, US
Dental Technologies, Inc.
Lincolnwood, IL, US
Itena Clinical Villepinte
Villepinte Seine-Saint-Denis, FR
Tender Corporation
Littleton, NH, US
Nam Ha Viet Nam Trading Company Limited
Hanoi Ha Noi, VN
Centrix, Inc.
Shelton, CT, US
Sdi Ltd.
BAYSWATER Victoria, AU
Shandong Huge Dental Material Corporation
Rizhao Shandong, CN
Oketz Logistics Llc
Coral Gables, FL, US
Voco Gmbh
CUXHAVEN Lower Saxony, DE
Gc Corp.
ITABASHI-KU Tokyo, JP
Solventum Germany Gmbh
SEEFELD Bavaria, DE
Zapalign Llc
Fort Lauderdale, FL, US
Gc Dental Mexicana, S.a. De C.v.
Monterrey Nuevo Leon, MX
510(k) clearances
507 clearances for this product code
- The Belport Company Inc., DBA Gingi-PakAug 7, 2026
K261937 · PacTemp Automix NE
- DiaDent Group InternationalJul 9, 2026
K261166 · DIA-CEM
- GC America, Inc.May 18, 2026
K254109 · G-CEM UNIVERSAL
- Inter-Med, Inc.Apr 15, 2026
K253337 · REGEN Bioactive Cement
- Voco GmbHMar 20, 2026
K252606 · Bifix Veneer LC, Bifix Veneer Try-In
- Kulzer, LLCDec 19, 2025
K254063 · iCEM Universal Plus
- Rizhao Huge Biomaterials Company, Ltd.Dec 12, 2025
K252785 · TopCEM Vigor SA Self-Adhesive Resin Cement
- Shofu Dental CorporationDec 9, 2025
K252808 · GlasIonomer FX-LC