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)
Top companies in EBF
| Company | 510(k)s | Recalls |
|---|---|---|
| Kerr Corp. | 9 | 43 |
| Voco GmbH | 45 | 1 |
| Sybron Dental Specialties | 28 | 7 |
| Bisco, Inc. | 30 | 0 |
| Pulpdent Corp. | 29 | 0 |
| Scientific Pharmaceuticals, Inc. | 29 | 0 |
| Dentsply Intl. | 28 | 0 |
| Ivoclar North America, Inc. | 28 | 0 |
| Shofu Dental Corp. | 27 | 0 |
| GC America, Inc. | 24 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2026 | Henry 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 |
EBF | K051867 |
| Aug 25, 2026 | Henry 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 |
EBF | K040769 |
| Sep 6, 2024 | Ultradent 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 |
EBF | K201795 |
| Sep 6, 2024 | Ultradent 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 |
EBF | K201795 |
| Sep 6, 2024 | Ultradent 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 |
EBF | K974282 |
| Aug 31, 2020 | Ultradent 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 |
EBF | K974413 |
| Oct 1, 2019 | Voco 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 |
EBF | K102354 |
| Jan 31, 2019 | RHONDIUM 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 |
EBF | K143694 |
| Aug 3, 2017 | Ivoclar Vivadent, Inc. Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559 Terminated |
EBF | K884588 |
| Aug 3, 2017 | Ivoclar Vivadent, Inc. Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503 Terminated |
EBF | K884588 |
| Aug 3, 2017 | Ivoclar Vivadent, Inc. Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502 Terminated |
EBF | K884588 |
| Aug 3, 2017 | Ivoclar Vivadent, Inc. Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501 Terminated |
EBF | K884588 |
| Jul 8, 2015 | 3M 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 |
EBF | K110131 K122569 |
| Sep 19, 2013 | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical NX3 Try-In Gel. The product is used as a tooth shade resin material. Terminated |
EBF | K001899 |
| Feb 28, 2012 | Kerr 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 |
EBF | K072545 |
| Feb 13, 2012 | Sybron 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 |
EBF | K052106 |
| Feb 13, 2012 | Sybron 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 |
EBF | K052106 |
| Feb 13, 2012 | Sybron 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 |
EBF | K052106 |
| Feb 13, 2012 | Sybron 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 |
EBF | K052106 |
| Feb 11, 2012 | Sybron 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 |
EBF | K052106 |
| Feb 11, 2012 | Sybron Dental Specialties Artiste Nano-Hybrid Affected Product.
Syringe Part No. Value Pack Part. No Shade
N28A N28VA A1
N28B N28VB Terminated |
EBF | K052106 |
| Nov 3, 2011 | Kerr/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 |
EBF | K874189 |
| Nov 3, 2011 | Kerr/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 |
EBF | K874189 |
| Nov 3, 2011 | Kerr/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 |
EBF | K874189 |
| Nov 3, 2011 | Kerr/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 |
EBF | K874189 |
| Nov 3, 2011 | Kerr/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 |
EBF | K874189 |
| Dec 17, 2010 | Patterson 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 |
EBF | K013647 |
| Mar 2, 2010 | Sybron Dental Specialties Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA. Terminated |
EBF | K082671 |
| Nov 25, 2008 | Kerr Corp PREMISE KIT, PART NO. 33882, UNIDOSE PREMISE MINI KIT, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE KIT, PART NO. 32612, UNIDOSE PREMISE MASTER KIT, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32837, 10 PACK UNIDOSE PREMISA TRANSLUCENT AMBER (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32830, 10 PACK UNIDOSE PREMISA DESTIN A3 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32824, 10 PACK UNIDOSE PREMISA D2 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32823, 10 PACK UNIDOSE PREMISA C4 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32822, 10 PACK UNIDOSE PREMISA C3 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32818, 10 PACK UNIDOSE PREMISA B3 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32817, 10 PACK UNIDOSE PREMISA B2 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32815, 10 PACK UNIDOSE PREMISA A4 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32814, 10 PACK UNIDOSE PREMISA A3.5 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32813, 10 PACK UNIDOSE PREMISA A3 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32812, 10 PACK UNIDOSE PREMISA A2 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32811, 10 PACK UNIDOSE PREMISA A1 (INTERNATIONAL ONLY), dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 34086, 10 PACK UNIDOSE PREMISE A2 SAMPLE, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32678, 10 PACK UNIDOSE PREMISE TRANS CLEAR, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32677, 10 PACK UNIDOSE PREMISE TRANS GREY, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32676, 10 PACK UNIDOSE PREMISE TRANS AMBER, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32674, 10 PACK UNIDOSE PREMISE C2 OPAQUE, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32673, 10 PACK UNIDOSE PREMISE B2 OPAQUE, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32672, 10 PACK UNIDOSE PREMISE B1 OPAQUE, dental composite Terminated |
EBF | K060472 |
| Nov 25, 2008 | Kerr Corp PREMISE, PART NO. 32670, 10 PACK UNIDOSE PREMISE A3.5 OPAQUE, dental composite Terminated |
EBF | K060472 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.