1,266 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502

FDA Recall
Terminated ·Ivoclar Vivadent, Inc.·Product code EBF·August 3, 2017

Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)

FDA Recall
Open, Classified ·Orascoptic Surgical Acuity·Product code EBA·July 3, 2025

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 variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artist Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc.

FDA Recall
Terminated ·Sybron Dental Specialties·Product code EBF·October 22, 2010

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.

FDA Recall
Terminated ·Kerr/pentron Dba Kerr Corporation And Pentron Clinical·Product code EBF·March 31, 2011

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 limit particle distribution.

FDA Recall
Terminated ·Ultradent Products, Inc.·Product code EBF·August 31, 2020

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 Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A2, 20 - Dispensing tips, 29494. 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 A3, 20 - Dispensing tips, 29495. 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 B1, 20 - Dispensing tips, 29499. Revolution is a flowable light cure hybrid resin restorative.

FDA Recall
Terminated ·Patterson Dental Supply, Inc.·Product code EBF·October 15, 2010

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 agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artist Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc.

FDA Recall
Terminated ·Sybron Dental Specialties·Product code EBF·October 22, 2010

PREMISE, PART NO. 32658, 10 PACK UNIDOSE PREMISE B4, dental composite

FDA Recall
Terminated ·Kerr Corp·Product code EBF·September 5, 2008

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.

FDA Recall
Completed ·RHONDIUM LIMITED·Product code EBF·January 31, 2019

Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501

FDA Recall
Terminated ·Ivoclar Vivadent, Inc.·Product code EBF·August 3, 2017

PREMISE, PART NO. 32660, 10 PACK UNIDOSE PREMISE C2, dental composite

FDA Recall
Terminated ·Kerr Corp·Product code EBF·September 5, 2008

PREMISE, PART NO. 32662, 10 PACK UNIDOSE PREMISE C4, dental composite

FDA Recall
Terminated ·Kerr Corp·Product code EBF·September 5, 2008

PREMISE, PART NO. 32678, 10 PACK UNIDOSE PREMISE TRANS CLEAR, dental composite

FDA Recall
Terminated ·Kerr Corp·Product code EBF·September 5, 2008

PREMISE KIT, PART NO. 33882, UNIDOSE PREMISE MINI KIT, dental composite

FDA Recall
Terminated ·Kerr Corp·Product code EBF·September 5, 2008

PREMISE, PART NO. 32673, 10 PACK UNIDOSE PREMISE B2 OPAQUE, dental composite

FDA Recall
Terminated ·Kerr Corp·Product code EBF·September 5, 2008

PREMISE, PART NO. 32665, 10 PACK UNIDOSE PREMISE D4, dental composite

FDA Recall
Terminated ·Kerr Corp·Product code EBF·September 5, 2008

Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA.

FDA Recall
Terminated ·Sybron Dental Specialties·Product code EBF·February 23, 2009

PREMISE, PART NO. 32818, 10 PACK UNIDOSE PREMISA B3 (INTERNATIONAL ONLY), dental composite

FDA Recall
Terminated ·Kerr Corp·Product code EBF·September 5, 2008

PREMISE, PART NO. 32655, 10 PACK UNIDOSE PREMISE B1, dental composite

FDA Recall
Terminated ·Kerr Corp·Product code EBF·September 5, 2008

PREMISE, PART NO. 32817, 10 PACK UNIDOSE PREMISA B2 (INTERNATIONAL ONLY), dental composite

FDA Recall
Terminated ·Kerr Corp·Product code EBF·September 5, 2008