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Panels › Dental › Product code EMA · Class 2

Cement, Dental

Regulation 872.3275

10510(k)s in 12 months (509 all time)
0recalls in 12 months (16 all time)
13recalls that name a 510(k)
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Top companies in EMA

Company510(k)sRecalls
GC America, Inc.300
Voco GmbH262
Shofu Dental Corp.240
Dentsply Intl.190
Pulpdent Corp.140
Sybron Dental Specialties140
3M Company120
Bisco, Inc.92
Espe GmbH (Us)100
Coltene/Whaledent AG90
DateFirm and productCodeLinked 510(k)
Feb 16, 2024Voco GmbH
Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
Open, Classified		 EMAK090817
Feb 16, 2024Voco GmbH
IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
Open, Classified		 EMAK160774
Nov 7, 2023Family Dollar Stores, Llc.
DENTEMP ONE STEP .077OZ, SKU 902139
Open, Classified		 EMAK964773
Mar 6, 2023Preat Corp
PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
Open, Classified		 EMANone listed
Aug 17, 2022Family Dollar Stores, Llc.
DENTEMP ONE STEP .077OZ, SKU 902139
Open, Classified		 EMAK964773
Feb 25, 2020Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is to be used for the cementation of indirect restora
Terminated		 EMAK001899
K191548
Mar 14, 2012Kerr Corporation
Brand Name: TempSpan CMT Temporary Cement, a temporary cement. Part Number: N69CA. The intended use of this device is to affix a temporary dental devices such as crowns or bridges to a tooth.
Terminated		 EMANone listed
Feb 24, 2012Kerr Corporation
Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation of porcelain, resin, and metal-based inlays, onlays, crowns, bridges, and posts.
Terminated		 EMAK060698
Jan 11, 2012Kerr Corporation
Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product Description and Intended Use: The intended use of this device is for internal color characterization and includes 3 o
Terminated		 EMANone listed
Jan 11, 2012Henry Schein, Inc.
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 Automix tips (regular) 4:1, 10 Automix tips (
Terminated		 EMAK073209
Jan 11, 2012Kerr/pentron Dba Kerr Corporation And Pentron Clinical
Dental cement under the brand name Cement-It and Natural Elegance (private label of Cement-It). The intended use of this device is to affix dental devices such as crowns or bridges onto the tooth. Ce
Terminated		 EMAK000173
Nov 14, 2011Kerr/pentron Dba Kerr Corporation And Pentron Clinical
Breeze Self-Adhesive Resin Cement, Part Number: N97A, Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts
Terminated		 EMAK060698
Oct 23, 2009Kerr Corp
Kerr TempBond Clear, Part # 33351, 1717 West Collins Avenue, Orange, CA 92867. Intended for use in a dual-cured, temporary resin-based cement designed to be used in conjunction with temporary restor
Terminated		 EMAK982590
Aug 25, 2008Bisco Inc
Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Opaque; The product is intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix
Terminated		 EMAK060701
Aug 25, 2008Bisco Inc
Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Translucent; The product is intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to
Terminated		 EMAK060701
Sep 23, 2006Kerr Corp
TempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637
Terminated		 EMAK982590

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