FDA.reportPublic FDA data

DENTSPLY IH Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12228021000120733DENTSPLY IH Inc.1Y2026-01-01590 LINCOLN STREET Waltham MA US 02451

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2121681839639092K981858ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREWDZE1999-03-22
2121681068881545K252343Atlantis® Abutments in TitaniumNHA2025-12-09
2121682061652889K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsNHA2025-11-21
2121681435569526K250081Atlantis® Abutments in TitaniumNHA2025-04-11
2121681476210444K193529ATLANTIS Abutment for MIS Conical Connection ImplantsNHA2020-03-05
2121682040474611K181189ATLANTIS Conus StructureNHA2018-07-18
2121681902964812K172225Atlantis Abutment for MIS ImplantNHA2017-11-30
2121681150482130K163398ATLANTIS suprastructuresNHA2017-08-14
2121681150324452K163350Multibase Abutments EV and ATLANTIS SuprastructuresNHA2017-03-31
2121681187310400K161030ATLANTIS Abutment for CONELOG implantNHA2016-08-26
2121681171333802K160626ATLANTIS Abutment for HIOSSEN ET implantNHA2016-08-29
2121681359577246K152247ATLANTIS CrownEIH2016-01-29
2121681165708896K151039ATLANTIS Abutment for NobelActive 3.0NHA2016-01-14
2121681149542215K130999OSSEOSPEED PROFILE EVDZE2013-10-25
2121681086007786K130216ATLANTIS STRAUMANN BONE LEVEL ABUTMENTNHA2013-05-01
2121681654775071K121810OSSEOSPEED ANGLED ABUTMENT EVNHA2013-01-23
2121681986173087K120414OSSEOSPEED PLUSDZE2012-07-31
2121681486772529K120338ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIANHA2012-07-05
2121681418789518K113003ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...NHA2012-03-01
2121681644367314K112138ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANTNHA2011-12-01
2121681259595353K111287ASTRA TECH IMPLANT SYSTEMDZE2011-09-26
2121681945621438K110640ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENTNHA2011-06-10
2121681474114023K110356ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENTNHA2011-06-10
2121681214549613K103759ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANTNHA2011-04-08
2121681212489489K103020ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENTNHA2011-02-03
2121681807833242K101004ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENTNHA2010-08-16
2121681343517749K093780ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENTNHA2010-04-16
2121681087383550K093483ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENTNHA2009-12-22
2121681970375251K091920ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBELNHA2009-09-28
2121681552030310K083871ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONENHA2009-04-15
2121681875375059K081666ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTSNHA2008-10-07
2121681296317169K080156OSSEOSPEED TM PROFILE SYSTEMDZE2008-09-17
2121681554226596K073540ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANTNHA2008-02-29
2121681034041519K073258ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI + ABUTMENTNHA2008-02-14
2121681290681103K072483ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTSNHA2007-11-16
2121681013286801K071946ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTSNHA2007-10-05
2121681866832944K070833ATLANTIS ABUTMENT FOR ASTRA IMPLANTNHA2007-06-22
2121681641339220K063734ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACENHA2007-03-02
2121681823566365K062277ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACENHA2006-12-20
2121681633861429K062197ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENTNHA2007-02-28
2121681940400070K062069ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANTNHA2007-02-14
2121681672987664K053654ATLANTIS ABUTMENT FOR NOBEL REPLACE INTERFACENHA2006-07-31
2121681708008426K053450ATLANTIS ABUTMENT FOR ZIMMER INTERFACENHA2006-03-03
2121681436708973K053373ATLANTIS ABUTMENT FOR ZIMMER INTERFACENHA2006-06-30
2121681001948917K052070ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCONIA, ATLANTIS GEMEINI + ABUTMENT IN ZIRCONIANHA2005-10-14
2121681492870822K051652ATLANTIS ABUTMENT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI+ ABUTMENTNHA2005-07-22
2121681136578367K051011ENDOSSEOUS DENTAL IMPLANT ABUTMENTNHA2005-07-12
2121681516629905K050052ATLANTIS ABUTMENT FOR STRAUMANN INTERFACENHA2005-03-07
2121681197734131
2121681631845077
2121681835467215

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NHA422025-12-09
DZE52013-10-25
EIH12016-01-29