FDA.reportPublic FDA data

Nobel Biocare Services AG

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30086936723008693672Nobel Biocare Services AG1N2026-01-01Balz Zimmermann-Strasse 7 Kloten Zurich CH CH-8302

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1220791630558920K992538AMORPHOUS DIAMOND COATED SCREWDZE1999-11-23
1220791910913903K990846AMORPHOUS DIAMOND COATED DRILLDZI1999-06-10
1220791652367454K984287PROVISIONAL DENTAL IMPLANT SYSTEMDZE1999-03-01
1220791864053724K974828BRANEMARK SYSTEM(R) EBON(TM) FIXTUREDZE1998-03-24
1220791696266664K974150PROCERA PREPARABLE ABUTMENT SYSTEMNHA1998-01-23
1220792060810363K974123BRANEMARK SYSTEM DEC 600 DRILLING UNITDZE1998-05-26
1220791918722818K972475AURADAPT AUBTMENT SYSTEMNHA1997-09-12
1220791151040752K970953E-TYPE SPEED REDUCER CONTRA ANGLEKMW1997-04-15
1220791790563980K970499BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEMDZE1997-10-16
1220791472855348K970073BIO-ESTHETIC INDIRECT ABUTMENTNHA1997-07-03
1220791307690834K964739STERI-OSS TIODIZED SCREWDZE1997-03-31
1220791394518368K964220REPLACE TITANIUM IMPLANT SYSTEMDZE1997-03-05
1220791215528328K963945STERI-OSS GOLD ATTACHMENT SYSTEMDZE1997-02-11
1220791651565211K962130BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTUREDZE1996-07-22
1220791527778215K961737CERA ONE ABUTMENT SYSTEMDZE1996-07-10
1220791623966591K96173617 ANGULATED ABUTMENTNHA1996-07-18
1220791847505328K961728MIRUSCONE ABUTMENT SYSTEMNHA1996-07-10
1220791307281024K955697ABUTMENT RETRIEVAL KITDZE1996-01-30
1220791854880165K955372BALL ATTACHMENT SYSTEMDZE1996-01-23
1220791358262317K952676BRANEMARK SYSTEM BALL ATTACHMENT SYSTEMDZE1995-08-11
1220792059578494K945398BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTUREDZE1995-04-13
1220791052228355K944964BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEMDZE1995-02-28
1220791465148582K930155MINIBALL ABUTMENTDZE1994-02-14
1220791248917626K925780BRANEMARK SYSTEM HEALING CAPSDZE1993-04-14
1220791201961881K925779BRANEMARK SYSTEM TITANIUM HEALING ABUTMENTSNHA1993-04-20
1220791009334228K925777BRANEMARK SYSTEM ESTHETICONE ABUTMENT COMPLETEDZE1993-04-14
1220791133336959K925773BRANEMARK SYSTEM GOLD CYLINDERS AND SCREWSDZE1993-04-14
1220791301801124K925771BRANEMARK SYSTEM TITANIUM COVER SCREWSDZE1993-04-14
1220791172762018K925769BRANEMARK SYSTEM ABUTMENTS COMPLETENHA1993-04-14
1220791411738991K925767BRANEMARK SYSTEM SINGLE TOOTH ABUTMENTS,INST&COMP.DZE1993-10-20
1220791125633845K925766BRANEMARK SYSTEM TEMPORARY SOLUTIONSDZE1994-08-02
1220791606486532K925765BRANEMARK SYSTEM STANDARD 3.75MM FIXTUREDZE1993-10-05
1220791554302535K925764BRANEMARK SYSTEM 4.00 MM FIXTUREDZE1993-10-05
1220791882929873K925762BRANEMARK SYSTEM SELF-TAPPING FIXTUREDZE1993-10-12
1220791540561022K925761BRANEMARK SYSTEM 5.0 X 14MM FIXTUREDZE1993-10-05
1220791427116032K923695STERI-OSS SCREW STYLE CP TITANIUM IMPLANTDZE1993-12-10
1220791555858040K923484STERI-OSS TITANIUM SCREW SERIES IMPLANTDZE1993-12-13
1220791130378327K913255CERAMIC(TM) ABUTMENTDZE1994-08-05
1220791646364260K911961BRANEMARK SYSTEM-5.0MM FIXTUREDZE1991-07-25
1220791171989418K911592STERI-OSS TITANIUM PLAMA SPRAY CYLINDRICAL IMPLANTDZE1993-07-22
1220791878777552K910611NOBELPHARMA CERAONE ABUTMENT SYSTEMDZE1991-08-16
1220791707482324K905434ANGULATED ABUTMENT, COMPLETE,TITANIUM SDCA 102DZE1992-08-27
1220791051157244K900099THE O-RING SYSTEM - ORSDZE1991-01-15
1220791894058557K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNHA2026-08-06
1220791562687983K253988LiteSet TraysKCT2026-09-08
1220791441609503K252197Nobel Biocare S Series ImplantsDZE2026-02-18
1220791767233018K252086DTX Studio AssistMYN2025-11-17
1220791242873367K243834NobelZygoma TiUltra Implant systemDZE2025-08-25
1220791860896649K240346NobelProcera Zirconia Implant BridgeNHA2025-01-03
1220791331927804K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNHA2024-01-24
1220791113309029K231898DTX Studio Clinic (4.0)LLZ2023-12-08
1220791735236288K231219NobelZygoma PureSet™ TrayKCT2023-06-27
1220791959218864K223677Titanium Abutment Blank Nobel Biocare N1 TCCNHA2023-04-28
1220791646181057K221921DTX Studio Clinic 3.0MYN2023-03-28
1220791202541359K220339Esthetic Abutments Nobel Biocare N1NHA2022-09-16
1220792023653322K220048NobelProcera Zirconia N1 BaseNHA2022-07-29
1220791018478840K213562DTX Studio Clinic 3.0LLZ2022-03-25
1220791009204151K212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet TrayKCT2021-12-18
1220791172721114K211109N1 TiUltra TCC Implant SystemDZE2021-12-21
1220791443735118K203156DTX Studio ClinicLLZ2020-11-20
1220791995324858K202452NobelProcera Zirconia Implant BridgeNHA2020-12-03
1220791540413833K202344TiUltra Implants and Xeal AbutmentsDZE2020-11-16
1220791548640765K200810IPS CaseDesignerLLZ2020-10-08
1220791145544224K200040Universal Base Conical Connection (CC)NHA2020-03-30
1220792019571301K200040Universal Base Conical Connection (CC)NHA2020-03-30
1220791539903649K191475Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet PlateKCT2019-08-29
1220792013312773K181932DTX Studio designPNP2019-03-01
1220791017379329K181869On1 Universal AbutmentNHA2018-12-12
1220792041019938K181075PureSet TrayKCT2018-09-27
1220791032836138K173418NobelParallel Conical ConnectionDZE2019-02-21
1220791779388875K172854NobelPerfect AbutmentsNHA2017-12-14
1220791065146742K172352TREFOIL SystemDZE2017-10-20
1220791028238385K172224DTX Studio diagnoseLLZ2018-01-11
1220791931686060K171466NobelDesign, DTX Studio DesignNHA2017-11-29
1220791234855343K171142Healing Cap Multi-Unit TitaniumNHA2017-10-26
1220791369751608K170135TREFOIL SystemDZE2017-05-11
1220791096591130K163600Kit Boxes and Kit PlatesKCT2018-01-22
1220791442335741K163122NobelClinician, DTX Studio implantLLZ2017-01-31
1220791316991446K162043NobelProcera HT ML FCZ BridgeELL2016-11-22
1220791211681092K161655On1 ConceptNHA2017-02-28
1220791076416422K161634IPS CaseDesignerLLZ2016-11-10
1220791371717902K161598NobelZygoma 0°DZE2017-03-14
1220791505818492K161435Temporary Snap AbutmentNHA2016-11-22
1220791406519338K161416Multi-unit Abutment PlusNHA2017-03-16
1220791428004703K160158NobelProcera HT ML FCZ Implant Bridge and FrameworkNHA2016-07-25
1220791781571393K160119NobelSpeedy GroovyDZE2016-06-02
1220791508788811K153534NobelProcera HT ML Full Contour Zirconia CrownELL2016-06-06
1220791010521911K153036NobelDesign SoftwareNHA2016-06-02
1220791006357899K152836TREFOIL SystemDZE2016-04-11
1220791340027211K152093NobelZygoma 45°DZE2016-03-16
1220791459025160K142260NobelActiveDZE2015-05-11
1220791825769550K133731NOBELACTIVE WIDE PLATFORM (WP)DZE2014-05-08
1220791260574439K132749NOBELPROCERA OVERDENTURE BARNHA2014-07-24
1220791746788369K132746NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTIONNHA2014-01-30
1220791129465532K123976NOBELCLINICIANLLZ2013-03-26
1220791085345574K122602NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMSNHA2013-03-13
1220791572949680K120954NOBELPROCERA PEEK ABUTMENTSNHA2013-06-05
1220791366575760K112259NOBELACTIVE 3.0 GOLDADAPT ABUTMENTSNHA2011-10-28
1220791498935270K11158115 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVENHA2011-06-23
1220791680674146K110171NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMSNHA2011-06-15
1220791358880249K102436NOBEL ACTIVE 3.0DZE2010-12-09
1220791837103900K101714NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMSNHA2010-08-31
1220791677990921K100512NOBELPROCERA IPS E.MAX CROWNEIH2010-08-20
1220791532018672K093643MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMSNHA2010-06-24
1220791905790207K091907NOBELPROCERA IMPLANT BRIDGE ZIRCONIANHA2009-10-06
1220791913512605K091904NOBELPROCERA ZI ABUTMENTNHA2009-09-25
1220791251110793K091848NOBEL/PROCERA IMPLANT BRIDGENHA2009-10-16
1220791800594955K091756NOBELPROCERA TI ABUTMENTNHA2009-09-22
1220791425590417K090630NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)FZE2009-06-02
1220791117206396K090069PROCERA IMPLANT BRIDGE OVERDENTURENHA2009-05-07
1220791040367242K083205NOBELACTIVE 8.5 MM & 18.0 MMDZE2009-02-13
1220791039350693K083100GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RPNHA2008-11-19
1220792032195780K073142NOBELREPLACE HEXAGONAL IMPLANTDZE2008-01-11
1220791671802763K072570NOBELACTIVE MULTI UNIT ABUTMENTNHA2007-12-28
1220791211985702K072129NOBELACTIVE ZIRCONIA ABUTMENTNHA2008-02-22
1220792069635068K071370NOBELACTIVE INTERNAL CONNECTION IMPLANTDZE2007-08-03
1220791444691655K071182PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013ELL2007-07-11
1220791043880658K063592ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW PS RP-NP, 34553, ABUTMENT SCREW PS WP-RP, 34554NHA2007-02-27
1220791200639811K062566NOBELREPLACE TAPERED CONICAL CONNECTIONDZE2006-12-06
1220791125719248K061529PROCERA ZIRCONIA ABUTMENT FOR CAMLOG IMPLANT SYSTEMNHA2006-08-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE672026-02-18
NHA562026-08-06
LLZ82023-12-08
KCT62026-09-08
ELL42016-11-22
EBW32006-05-03
MYN22025-11-17
PNP12019-03-01
EIH12010-08-20
FZE12009-06-02
EGS12001-06-28
DZI11999-06-10
KMW11997-04-15

PMN#