ClearanceBrief
Company · DE

3M Espe AG Dental Products

FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2023. Name variants (Inc, Corp, punctuation) are merged.

37510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)

Product codes

CodeDeviceRecords
EMACement, Dental8
KLEAgent, Tooth Bonding, Resin8
EBFMaterial, Tooth Shade, Resin7
EIHPowder, Porcelain3
ELWMaterial, Impression3
EBGCrown And Bridge, Temporary, Resin2
LBHVarnish, Cavity2
NHAAbutment, Implant, Dental, Endosseous2
EJKLiner, Cavity, Calcium Hydroxide1
KOJAirbrush1
MVLCord, Retraction1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 10, 2023K2313383M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment
3M Espe Dental Products
LBH
Feb 6, 2023K2302703M™ VitCal Liner/Base
3M Espe Dental Products
EJK
Jun 13, 2022K2216953M Filtek Supreme Flowable Restorative
3M Company Espe Dental Products
EBF
May 29, 2019K1911223M RelyX Pediatric Resin Modified Glass Ionomer Cement
3M Espe Dental Products
EMA
Jan 2, 2019K1834763M Filtek Universal Restorative
3M Espe Dental Products
EBF
May 8, 2014K141081FILTEK BULK FILL POSTERIOR RESTROATIVE
3M Espe Dental Products
EBF
Mar 19, 2012K120453FILTEK BULK FILL FLOWABLE RESTORATIVE
3M Espe Dental Products
EBF
May 5, 2011K111185RELYX LUTING PLUS AUTOMIX
3M Espe Dental Products
EMA
Jan 21, 2011K110131LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE
3M Espe Dental Products
EBF
Jun 22, 2010K100908UNICEM HM
3M Espe AG Dental Products, DE
EMA
Jun 2, 2010K100756MALTA
3M Espe AG Dental Products, DE
EMA
Apr 8, 2010K094007UNICEM
3M Espe AG Dental Products, DE
EMA
Mar 10, 2010K092141VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH
3M Espe Dental Products
LBH
Feb 19, 2010K093721COSP2
3M Espe AG Dental Products, DE
MVL
Sep 25, 2009K091826ELEGANT
3M Espe AG Dental Products, DE
EIH
Sep 21, 2009K090718BELLUS SHADING KIT
3M Espe AG Dental Products, DE
EIH
Mar 26, 2008K080514PECD-01 AND PECD QUICK-01
3M Espe AG Dental Products, DE
ELW
Feb 26, 2008K072055LAVA FRAME, LAVA FRAME SHADE
3M Espe AG Dental Products, DE
NHA
Jan 17, 2008K073395GILB-2, GLASS IONOMER PROTECTIVE COATING
3M Espe Dental Products
EMA
Jan 9, 2008K073296TEMPXN28
3M Espe AG Dental Products, DE
EBG
Jul 25, 2007K071131UNO
3M Espe AG Dental Products, DE
KLE
Jul 17, 2007K071260HERMES BOND 3
3M Espe AG Dental Products, DE
KLE
May 22, 2007K070956SEA2 SELF ETCH ADHESIVE
3M Espe Dental Products
KLE
Nov 17, 2006K062493LAVA SOFTWARE
3M Espe AG Dental Products, DE
NHA
Oct 25, 2006K062292UNICEM
3M Espe Dental Products, DE
EMA
Apr 24, 2006K060684ADPER PROMPT, ADPER PROMPT L-POP
3M Espe AG Dental Products, DE
KLE
Jan 18, 2006K053438GLASS CERAMICS
3M Espe AG Dental Products, DE
EIH
Jul 21, 2005K051797FUTURE WASH/YPS
3M Espe AG Dental Products, DE
ELW
Jan 10, 2005K043043HERMES BOND 2
3M Espe AG Dental Products, DE
KLE
May 10, 2004K040857MODIFICATION TO ADPER PROMPT
3M Espe AG Dental Products, DE
KLE
Feb 24, 2004K033996HERMES
3M Espe AG Dental Products, DE
EBF
Feb 6, 2004K033974HERMES BOND
3M Espe AG Dental Products, DE
KLE
Nov 21, 2003K033022PROTEMP 3 GARANT
3M Espe AG Dental Products, DE
EBG
Aug 11, 2003K032001POLY Q (GARANT L, PENTA M, PENTA H)
3M Espe AG Dental Products, DE
ELW
Aug 1, 2002K021450CLINPRO PROPHY POWDER
3M Espe AG Dental Products, DE
KOJ
Apr 4, 2002K020946ADPER PROMPT
3M Espe AG Dental Products, DE
KLE
Mar 25, 2002K020256UNICEM
3M Espe AG Dental Products, DE
EMA

Latest recalls

DateFirm and productCodeLinked 510(k)
May 11, 20073M Espe Dental Products
3M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade, manufactured by 3M. ESPE is a radiopaque , color stable light-cured resin cement indicated for bonding veneers fabricate
Terminated		 EBFK991961
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