ClearanceBrief
Panels › Dental › Product code EBF · Class 2

Material, Tooth Shade, Resin

Regulation 872.3690

19510(k)s in 12 months (937 all time)
2recalls in 12 months (71 all time)
71recalls that name a 510(k)
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Top companies in EBF

DateFirm and productCodeLinked 510(k)
Aug 25, 2026Henry Schein Inc.
Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product Code 1840; Lots 2529604, 2538147, 2608145 2) 949-3595, Mfr Product Code 1841; Lots 25390
Open, Classified
EBFK051867
Aug 25, 2026Henry Schein Inc.
Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code 1479; Lots 2536179, 2606429 2) 114-3934, Mfr Product Code 1480; Lot 2539064 3) 114-3935, Mfr Produc
Open, Classified
EBFK040769
Sep 6, 2024Ultradent Products, Inc.
Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend universal composite is a light-cu
Open, Classified
EBFK201795
Sep 6, 2024Ultradent Products, Inc.
Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shad
Open, Classified
EBFK201795
Sep 6, 2024Ultradent Products, Inc.
Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA e
Open, Classified
EBFK974282
Aug 31, 2020Ultradent Products, Inc.
PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1m average particle size with narrow upper li
Terminated
EBFK974413
Oct 1, 2019Voco GmbH
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities i
Terminated
EBFK102354
Jan 31, 2019RHONDIUM LIMITED
Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, New Zealand.
Completed
EBFK143694
Aug 3, 2017Ivoclar Vivadent, Inc.
Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559
Terminated
EBFK884588
Aug 3, 2017Ivoclar Vivadent, Inc.
Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503
Terminated
EBFK884588
Aug 3, 2017Ivoclar Vivadent, Inc.
Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502
Terminated
EBFK884588
Aug 3, 2017Ivoclar Vivadent, Inc.
Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
Terminated
EBFK884588
Jul 8, 20153M Company - Health Care Business
Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorati
Terminated
EBFK110131
K122569
Sep 19, 2013Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
NX3 Try-In Gel. The product is used as a tooth shade resin material.
Terminated
EBFK001899
Feb 28, 2012Kerr Corporation
Brand Name: Fusio Liquid Dentin, part number N21SB, N21SC. Product Usage: The intended use of this device is as a self-etch, self-adhesive flowable resin composite indicated for light-cured dental r
Terminated
EBFK072545
Feb 13, 2012Sybron Dental Specialties
Flow Tec Part Number 3786-754, Syringe Lot Number 165741 The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding age
Terminated
EBFK052106
Feb 13, 2012Sybron Dental Specialties
Flow Tec Part Number 3784-514, Syringe Lot Number 165741 The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding age
Terminated
EBFK052106
Feb 13, 2012Sybron Dental Specialties
Artiste Flowable Value Pack Part Number N28VA, Syringe Lot Number 165741 The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variet
Terminated
EBFK052106
Feb 13, 2012Sybron Dental Specialties
Artiste Flowable Part Number N28A, Syringe Lot Number 165741 The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding
Terminated
EBFK052106
Feb 11, 2012Sybron Dental Specialties
Flow Tec Nano-Hybrid Flowable Affected Product Syringe Part No. Value Pack Part. No. Shade BEN3784-514 BEN3786-754 A1 BEN3784-532 BEN3786-763 A2 BEN3784-541 BEN3784-738 A3 BEN3784-550 BEN3784-747 A3.
Terminated
EBFK052106
Feb 11, 2012Sybron Dental Specialties
Artiste Nano-Hybrid Affected Product. Syringe Part No. Value Pack Part. No Shade N28A N28VA A1 N28B N28VB
Terminated
EBFK052106
Nov 3, 2011Kerr/pentron Dba Kerr Corporation And Pentron Clinical
37% Etching Gel-5ml syringe, part #N01IB The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent.
Terminated
EBFK874189
Nov 3, 2011Kerr/pentron Dba Kerr Corporation And Pentron Clinical
37% Etching Gel-3ml syringe, part #N01H The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent.
Terminated
EBFK874189
Nov 3, 2011Kerr/pentron Dba Kerr Corporation And Pentron Clinical
37% Etching Gel-1ml syringe 50 pk, part # T06B The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent.
Terminated
EBFK874189
Nov 3, 2011Kerr/pentron Dba Kerr Corporation And Pentron Clinical
37% Etching Gel-1ml syringe 20 pk, part # T06A The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent.
Terminated
EBFK874189
Nov 3, 2011Kerr/pentron Dba Kerr Corporation And Pentron Clinical
37% Etching Gel-1ml syringe, part # T06 The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent.
Terminated
EBFK874189
Dec 17, 2010Patterson Dental Supply, Inc.
SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A1, 20 - Dispensing tips, 29493. SDS Kerr Revolution
Terminated
EBFK013647
Mar 2, 2010Sybron Dental Specialties
Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA.
Terminated
EBFK082671
Nov 25, 2008Kerr Corp
PREMISE KIT, PART NO. 33882, UNIDOSE PREMISE MINI KIT, dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE KIT, PART NO. 32612, UNIDOSE PREMISE MASTER KIT, dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 32837, 10 PACK UNIDOSE PREMISA TRANSLUCENT AMBER (INTERNATIONAL ONLY), dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 32830, 10 PACK UNIDOSE PREMISA DESTIN A3 (INTERNATIONAL ONLY), dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 32824, 10 PACK UNIDOSE PREMISA D2 (INTERNATIONAL ONLY), dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 32823, 10 PACK UNIDOSE PREMISA C4 (INTERNATIONAL ONLY), dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 32822, 10 PACK UNIDOSE PREMISA C3 (INTERNATIONAL ONLY), dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 32818, 10 PACK UNIDOSE PREMISA B3 (INTERNATIONAL ONLY), dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 32817, 10 PACK UNIDOSE PREMISA B2 (INTERNATIONAL ONLY), dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 32815, 10 PACK UNIDOSE PREMISA A4 (INTERNATIONAL ONLY), dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 32814, 10 PACK UNIDOSE PREMISA A3.5 (INTERNATIONAL ONLY), dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 32813, 10 PACK UNIDOSE PREMISA A3 (INTERNATIONAL ONLY), dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 32812, 10 PACK UNIDOSE PREMISA A2 (INTERNATIONAL ONLY), dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 32811, 10 PACK UNIDOSE PREMISA A1 (INTERNATIONAL ONLY), dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 34086, 10 PACK UNIDOSE PREMISE A2 SAMPLE, dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 32678, 10 PACK UNIDOSE PREMISE TRANS CLEAR, dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 32677, 10 PACK UNIDOSE PREMISE TRANS GREY, dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 32676, 10 PACK UNIDOSE PREMISE TRANS AMBER, dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 32674, 10 PACK UNIDOSE PREMISE C2 OPAQUE, dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 32673, 10 PACK UNIDOSE PREMISE B2 OPAQUE, dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 32672, 10 PACK UNIDOSE PREMISE B1 OPAQUE, dental composite
Terminated
EBFK060472
Nov 25, 2008Kerr Corp
PREMISE, PART NO. 32670, 10 PACK UNIDOSE PREMISE A3.5 OPAQUE, dental composite
Terminated
EBFK060472

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