47 results
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96ms
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Sources: EU EUDAMED, US FDA
SINGLE USE DENTAL, INC
FDA registration
SINGLE USE DENTAL, INC·1 product·🇺🇸 United States
ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations
FDA Enforcement
Class II
·Terminated·Ivoclar Vivadent, Inc.·November 27, 2013
Dental Explorer Single End #7, Mfr. Part Code/Product Code 100-7409. Distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. The product is labeled in part, HENRY SCHEIN 100-7409 Explorer - Single End #7 SE. +H65810074090C. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. --- This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling).
FDA Recall
Terminated
·Hu-Friedy Mfg Co, Inc.·Product code EKB·January 7, 2005
AMI
FDA Adverse Event
Other
·AIRWAY MANAGEMENT INC.·Product code LRK·July 10, 2013
ETHILON BLUE 1.0M 45CM W/NDL
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAR·January 29, 2025
ETHILON BLUE 1.0M 45CM W/NDL
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAR·January 29, 2025
ETHILON BLUE 1.0M 45CM W/NDL
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAR·January 29, 2025
ETHILON BLUE 1.0M 45CM W/NDL
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAR·January 29, 2025
ETHILON BLUE 1.0M 45CM W/NDL
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAR·January 29, 2025
SUTURE UNKNOWN
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAK·June 27, 2024
SUTURE UNKNOWN
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAK·June 27, 2024
Dental Explorer #23 S/E, Mfr. Part Code/Product Code 100-3620, distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. The product is labeled in part, HENRY SCHEIN 100-3620 Explorer-Single End #23 SE. +H658100362003. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. --- This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling).
FDA Recall
Terminated
·Hu-Friedy Mfg Co, Inc.·Product code EKB·January 7, 2005
STRAUMANN MEMBRANE FLEX
FDA Adverse Event
Injury
·COLLAGEN MATRIX, INC.·Product code NPL·May 28, 2025
"***3i Incise Custom-Made Label. QP157 Approved 07/09/10*** 3i inc se Custom-made Dental Framework***Biomet 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 800-342-5454 www.biomet3i.com Please consult instructions for use and recommendation***For Dental Lab use ONLY Non-sterile/For single Use***" Indicated for use in restorative procedure to affix the final prosthesis to the abutment. Coping and frameworks provide the base structure for final porcelain application as the final step of creating a restoration. The devices are intended to be used to create final restoration for dental reconstruction with either a prepared tooth or dental implant abutment.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NSP·December 1, 2010
ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations
FDA Recall
Terminated
·Ivoclar Vivadent, Inc.·Product code MZW·September 23, 2013
VICRYL RAP UND 75CM M1.5 USP4/0 SGLE ARMED FS-2
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·July 24, 2024
VICRYL RAP UND 75CM M1.5 USP4/0 SGLE ARMED FS-2
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·July 24, 2024
ZIMMER M/L TAPER FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code LZO·May 7, 2014
HENRY SCHEIN(R) 100-3620 Explorer-Single End #23 SE. Barcode *+H658100362003*. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). 510 (k) exempt, Class I device, Device Listing # B057701.
FDA Recall
Terminated
·Hu-Friedy Mfg Co, Inc.·Product code EKB·March 29, 2004
VICRYL RAP UND 75CM M1.5 USP4/0 SGLE ARMED FS-2
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·July 24, 2024