FDA.reportPublic FDA data

Karen McCommons

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30064117803006411780Karen McCommons1N2026-01-014555 Riverside Dr Palm Beach Gardens FL US 33410
30098408063009840806Karen McCommons1N2026-01-014555 Riverside Dr Palm Beach Gardens FL US 33410

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1467681548898267K982305SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENTDZE1998-09-22
1467721548898267K982305SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENTDZE1998-09-22
1467721986093735K9724443I INNOVATIVE IMPLANTS AND COVER SCREWSDZE1997-08-26
1467721302443222K970752SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEMDZE1997-06-23
1467681411039464K962106SPLINE DENTAL IMPLANT SYSTEMSDZE1996-08-29
1467721411039464K962106SPLINE DENTAL IMPLANT SYSTEMSDZE1996-08-29
1467721092139772K960021CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMSDZE1996-02-08
1467681541295675K9556195.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMSDZE1996-03-08
1467721541295675K9556195.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMSDZE1996-03-08
1467681615070664K953101PARAGON IMPLANT SYSTEMDZE1995-12-21
1467721615070664K953101PARAGON IMPLANT SYSTEMDZE1995-12-21
1467681887049702K944327INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEMDZE1995-05-16
1467721887049702K944327INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEMDZE1995-05-16
1467681186272650K943604INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEMDZE1996-02-08
1467721186272650K943604INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEMDZE1996-02-08
1467721186794495K933969TAPERED ABUTMENT AND RELATED COMPONENTSDZE1994-04-26
1467681663180474K932274INTEGRAL III DENTAL IMPLANT ABUTMENTDZE1993-11-05
1467721663180474K932274INTEGRAL III DENTAL IMPLANT ABUTMENTDZE1993-11-05
1467721359539394K932123IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEMDZE1994-05-27
1467721114919353K912059PRE-ANGLED ABUTMENTSDZE1992-02-11
1467721208211164K904228OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED)DZE1990-11-09
1467681939883803K902969SCREW-VENT ENDOSSEOUS HA COATED DENTAL IMPLANTSDZE1990-12-17
1467721939883803K902969SCREW-VENT ENDOSSEOUS HA COATED DENTAL IMPLANTSDZE1990-12-17
1467681028083248K900694CASTABLE ABUTMENTSDZE1991-02-11
1467721028083248K900694CASTABLE ABUTMENTSDZE1991-02-11
1467681397480683K900549INTEGRAL PLUS BIOINTEGRATED DENTAL IMPLANT SYSTEMDZE1990-06-28
1467721397480683K900549INTEGRAL PLUS BIOINTEGRATED DENTAL IMPLANT SYSTEMDZE1990-06-28
1467721641110971K900545O-RING PROSTHETIC ATTACHMENT DEVICEDZE1990-06-22
1467721707391428K900179SCREW-VENT ENDOSSEOUS IMPLANT ABUTMENTSDZE1991-02-20
1467721856731068K891613OVERDENTURE ATTACHMENTDZE1989-10-10
1467681023646807K883717BIO-VENTDZE1989-09-01
1467721023646807K883717BIO-VENTDZE1989-09-01
1467721610997710K871863ADBUTMENT CYLINDER AND SCREWDZE1987-07-10
1467681662857390K840750HYDROXYLAPATITE COATED ENDOSSEOUS DENTDZE1984-04-13
1467721662857390K840750HYDROXYLAPATITE COATED ENDOSSEOUS DENTDZE1984-04-13
1467721004161573K241753Immediate Molar ImplantsDZE2024-10-23
1467721810025928K220978TSX ImplantsDZE2022-09-14
1467721947061869K213672T3 Pro ImplantsDZE2022-03-28
1467681947061869K213672T3 Pro ImplantsDZE2022-03-28
1467721608816990K212730BellaTek Encode Emergence Healing AbutmentsNHA2021-12-21
1467681801785528K192522TSV BellaTek Express and BellaTek Flex AbutmentsNHA2019-12-09
1467721801785528K192522TSV BellaTek Express and BellaTek Flex AbutmentsNHA2019-12-09
1467721020238176K183138Certain BellaTek Express and BellaTek Flex AbutmentsNHA2019-07-02
1467681020238176K183138Certain BellaTek Express and BellaTek Flex AbutmentsNHA2019-07-02
1467721791921198K173374TSV BellaTek Encode Healing AbutmentsNHA2017-12-13
1467721904489996K1505713i T3 Short ImplantsDZE2015-11-20
1467681904489996K1505713i T3 Short ImplantsDZE2015-11-20
1467681654259532K143528Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant SystemNHA2015-05-01
1467721654259532K143528Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant SystemNHA2015-05-01
1467721692421599K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumNHA2015-06-25
1467721753359909K142572Zimmer Zfx Abutment for Zimmer 3.1mmD Implant SystemNHA2015-01-21
1467681457721961K142082ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENTDZE2014-10-28
1467721457721961K142082ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENTDZE2014-10-28
1467681389769953K133339ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATEDDZE2014-03-04
1467721389769953K133339ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATEDDZE2014-03-04
1467721734065560K1330493I T3(R) EXTERNAL HEX DENTAL IMPLANTSDZE2014-01-08
1467681734065560K1330493I T3(R) EXTERNAL HEX DENTAL IMPLANTSDZE2014-01-08
1467681674342696K132258ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEMDZE2013-11-19
1467721674342696K132258ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEMDZE2013-11-19
1467681353798600K130949CP4 OSSEOTITE CERTAIN DENTAL IMPLANTSDZE2013-07-30
1467721353798600K130949CP4 OSSEOTITE CERTAIN DENTAL IMPLANTSDZE2013-07-30
1467681362468327K122300T3 DENTAL IMPLANTDZE2013-01-30
1467721362468327K122300T3 DENTAL IMPLANTDZE2013-01-30
1467721147894840K120873ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEMNHA2012-11-08
1467721267758093K120776ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTIONNHA2012-09-11
1467681548244297K113753ZIMMER DENTAL TAPERED SCREW-VENT XDZE2012-08-30
1467721548244297K113753ZIMMER DENTAL TAPERED SCREW-VENT XDZE2012-08-30
1467681605746043K113092ZIMMER CONTOUR PROVISIONAL COPINGNHA2012-01-23
1467721605746043K113092ZIMMER CONTOUR PROVISIONAL COPINGNHA2012-01-23
1467721315719229K112730ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTIONNHA2012-01-13
1467681192317752K112160TAPERED SCREW-VENT X IMPLANTDZE2011-12-14
1467721192317752K112160TAPERED SCREW-VENT X IMPLANTDZE2011-12-14
1467681734880436K111889ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANTDZE2011-12-06
1467721734880436K111889ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANTDZE2011-12-06
1467681924062547K111853ANGLED TAPERED ABUTMENTNHA2011-12-08
1467721924062547K111853ANGLED TAPERED ABUTMENTNHA2011-12-08
1467681666194377K111852ANODIZED HEALING COLLARNHA2011-08-11
1467721666194377K111852ANODIZED HEALING COLLARNHA2011-08-11
1467681537841534K111216OSSEOTITE 2 DENTAL IMPLANTSDZE2011-11-18
1467721537841534K111216OSSEOTITE 2 DENTAL IMPLANTSDZE2011-11-18
1467721337818674K110565ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACENHA2011-09-01

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE1622024-10-23
NHA852021-12-21
LYC12011-05-13