FDA.reportPublic FDA data

Keystone Dental Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30119361133011936113Keystone Dental Inc.1Y2026-01-0113645 Alton Pkwy Ste A Irvine CA US 92618
30038451383003845138Keystone Dental Inc.1N2020-04-255 Holland Building 209 Irvine CA US 92618
30059904993005990499KEYSTONE DENTAL, INC.1N2020-04-25154 Middlesex Turnpike BURLINGTON MA US 01803

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
D76815070K0Prima - Osteotome+1(781)328-3313sshahid@keystonedental.com
D76815070K0Prima - Osteotome+1(866)902-9272info@keystonedental.com
D76815258K0Prima - Drill+1(781)328-3313sshahid@keystonedental.com
D76815258K0Prima - Drill+1(866)902-9272info@keystonedental.com
D76815259K0Prima - Drill+1(781)328-3313sshahid@keystonedental.com
D76815259K0Prima - Drill+1(866)902-9272info@keystonedental.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
677871332945212K994205MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEMDZE2000-02-29
2237231332945212K994205MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEMDZE2000-02-29
2237271332945212K994205MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEMDZE2000-02-29
677871244013934K993894LIFECORE SINGLE TOOTH ABUTMENT SYSTEMDZE2000-03-08
2237231244013934K993894LIFECORE SINGLE TOOTH ABUTMENT SYSTEMDZE2000-03-08
2237271244013934K993894LIFECORE SINGLE TOOTH ABUTMENT SYSTEMDZE2000-03-08
677871350762162K991114REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEMDZE1999-07-14
2237231350762162K991114REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEMDZE1999-07-14
2237271350762162K991114REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEMDZE1999-07-14
677871998052813K970776LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENTDZE1997-05-27
2237231998052813K970776LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENTDZE1997-05-27
2237271998052813K970776LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENTDZE1997-05-27
2237271069632849K961511HAPSET HYDROXYLAPATITE BONE GRAFT PLASTERLZK1996-06-28
677871452523882K960288HA & TPS RESTORE SELF TAPPING DENTAL IMPLANT SYSTEMDZE1996-03-28
2237231452523882K960288HA & TPS RESTORE SELF TAPPING DENTAL IMPLANT SYSTEMDZE1996-03-28
2237271452523882K960288HA & TPS RESTORE SELF TAPPING DENTAL IMPLANT SYSTEMDZE1996-03-28
2237271437512692K955096CAPSET CALCIUM SULFATE BONE GRAFT PLASTERLYC1996-01-23
677871547102074K954865RESTORE HA DENTAL IMPLANT SYSTEMDZE1996-01-11
2237231547102074K954865RESTORE HA DENTAL IMPLANT SYSTEMDZE1996-01-11
2237271547102074K954865RESTORE HA DENTAL IMPLANT SYSTEMDZE1996-01-11
677871641599104K954819RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEMDZE1996-01-11
2237231641599104K954819RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEMDZE1996-01-11
2237271641599104K954819RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEMDZE1996-01-11
677871029290355K954512RESTORE SELF TAPPING DENTAL IMPLANT SYSTEMDZE1996-02-23
2237231029290355K954512RESTORE SELF TAPPING DENTAL IMPLANT SYSTEMDZE1996-02-23
2237271029290355K954512RESTORE SELF TAPPING DENTAL IMPLANT SYSTEMDZE1996-02-23
677871209402875K951111RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM)DZE1995-03-31
2237231209402875K951111RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM)DZE1995-03-31
2237271209402875K951111RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM)DZE1995-03-31
677871320277192K950624HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEMDZE1995-08-30
2237231320277192K950624HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEMDZE1995-08-30
2237271320277192K950624HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEMDZE1995-08-30
677871738046667K944069RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEMDZE1995-02-28
2237231738046667K944069RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEMDZE1995-02-28
2237271738046667K944069RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEMDZE1995-02-28
677871183083181K944068RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM)DZE1995-02-02
2237231183083181K944068RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM)DZE1995-02-02
2237271183083181K944068RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM)DZE1995-02-02
2237271740294251K943186CAPSET CALCIUM SULFATE BONE GRAFT PLASTERLYC1995-04-10
677871300152169K941554SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEMDZE1994-07-22
2237231300152169K941554SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEMDZE1994-07-22
2237271300152169K941554SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEMDZE1994-07-22
677871743680179K931468RESTORE HEX CYLINDER ENDOSSEOUS SYSTEMDZE1994-07-12
2237231743680179K931468RESTORE HEX CYLINDER ENDOSSEOUS SYSTEMDZE1994-07-12
2237271743680179K931468RESTORE HEX CYLINDER ENDOSSEOUS SYSTEMDZE1994-07-12
677871733136226K914137HA-BIONTEGRATED DENTAL IMPLANT SYSTEMSDZE1994-02-03
2237231733136226K914137HA-BIONTEGRATED DENTAL IMPLANT SYSTEMSDZE1994-02-03
2237271733136226K914137HA-BIONTEGRATED DENTAL IMPLANT SYSTEMSDZE1994-02-03
2237271583605137K910432HAPSET HYDROXYLAPATITE BONE GRAFT PLASTERLYC1991-05-01
2237231441401607K240966Prima Plus Conical Implant SystemDZE2024-07-09
2237231408536424K223814Genesis ACTIVE Implant SystemDZE2023-05-25
2237231591789688K221381KDG AbutmentsNHA2022-08-10
677871587193349K101545GENESIS IMPLANT SYSTEMDZE2010-10-28
2237231587193349K101545GENESIS IMPLANT SYSTEMDZE2010-10-28
2237271587193349K101545GENESIS IMPLANT SYSTEMDZE2010-10-28
677871204097852K093562ENDOSSEOUS DENTAL IMPLANTDZE2010-10-14
2237231204097852K093562ENDOSSEOUS DENTAL IMPLANTDZE2010-10-14
2237271204097852K093562ENDOSSEOUS DENTAL IMPLANTDZE2010-10-14
677871514797364K082651ENDOSSEOUS DENTAL IMPLANT SYSTEMDZE2008-12-22
2237231514797364K082651ENDOSSEOUS DENTAL IMPLANT SYSTEMDZE2008-12-22
2237271514797364K082651ENDOSSEOUS DENTAL IMPLANT SYSTEMDZE2008-12-22
677871638648530K073032PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTSNHA2007-11-16
2237231638648530K073032PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTSNHA2007-11-16
2237271638648530K073032PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTSNHA2007-11-16
677871933553622K072768RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTSDZE2007-10-23
2237231933553622K072768RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTSDZE2007-10-23
2237271933553622K072768RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTSDZE2007-10-23
677871564641584K072572PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTSNHA2007-10-05
2237231564641584K072572PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTSNHA2007-10-05
2237271564641584K072572PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTSNHA2007-10-05
677871862140523K072241PRIMACONNEX CAD/CAM ABUTMENT SYSTEMNHA2007-11-09
2237231862140523K072241PRIMACONNEX CAD/CAM ABUTMENT SYSTEMNHA2007-11-09
2237271862140523K072241PRIMACONNEX CAD/CAM ABUTMENT SYSTEMNHA2007-11-09
2237271947323102K071599EASYGUIDELLZ2007-07-11
677871755945682K071161ENDOSSEOUS DENTAL IMPLANT SYSTEMDZE2007-11-16
2237231755945682K071161ENDOSSEOUS DENTAL IMPLANT SYSTEMDZE2007-11-16
2237271755945682K071161ENDOSSEOUS DENTAL IMPLANT SYSTEMDZE2007-11-16
2237271227025051K071070OLYMPUS DENTAL IMPLANT SYSTEMDZE2007-10-23
677871607717513K070905ENDOSSEOUS DENTAL IMPLANT SYSTEMDZE2007-05-24
2237231607717513K070905ENDOSSEOUS DENTAL IMPLANT SYSTEMDZE2007-05-24
2237271607717513K070905ENDOSSEOUS DENTAL IMPLANT SYSTEMDZE2007-05-24
677871671061476K070841ENDOSSEOUS DENTAL IMPLANT SYSTEMDZE2007-06-21
2237231671061476K070841ENDOSSEOUS DENTAL IMPLANT SYSTEMDZE2007-06-21
2237271671061476K070841ENDOSSEOUS DENTAL IMPLANT SYSTEMDZE2007-06-21
677871386067706K062876PRIMACONNEX CERAMIC ABUTMENTSNHA2006-11-01
2237231386067706K062876PRIMACONNEX CERAMIC ABUTMENTSNHA2006-11-01
2237271386067706K062876PRIMACONNEX CERAMIC ABUTMENTSNHA2006-11-01
677871286253233K061169ENDOSSEOUS DENTAL IMPLANTDZE2006-06-20
2237231286253233K061169ENDOSSEOUS DENTAL IMPLANTDZE2006-06-20
2237271286253233K061169ENDOSSEOUS DENTAL IMPLANTDZE2006-06-20
677871064378058K060530SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.ELL2006-05-22
2237231064378058K060530SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.ELL2006-05-22
2237271064378058K060530SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.ELL2006-05-22
677871935351474K060332ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTYNUN2006-03-29
2237231935351474K060332ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTYNUN2006-03-29
2237271935351474K060332ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTYNUN2006-03-29
677871133850741K060306ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTYNUN2006-03-27
2237231133850741K060306ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTYNUN2006-03-27
2237271133850741K060306ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTYNUN2006-03-27
677871237643362K053643STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026NHA2006-01-23
2237231237643362K053643STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026NHA2006-01-23
2237271237643362K053643STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026NHA2006-01-23
2237271315715966K053478ENDOSSEOUS DENTAL IMPLANT SYSTEMDZE2006-04-05
677871313138201K052490ENDOSSEOUS DENTAL IMPLANT SYSTEMDZE2005-12-08
2237231313138201K052490ENDOSSEOUS DENTAL IMPLANT SYSTEMDZE2005-12-08
2237271313138201K052490ENDOSSEOUS DENTAL IMPLANT SYSTEMDZE2005-12-08
677871446930736K051614PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICSDZE2005-09-09
2237231446930736K051614PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICSDZE2005-09-09
2237271446930736K051614PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICSDZE2005-09-09
677871450682574K050506PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPSDZE2005-04-15
2237231450682574K050506PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPSDZE2005-04-15
2237271450682574K050506PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPSDZE2005-04-15
677871296638710K043573DYNAGRAFT II DENTALNUN2005-07-29
2237231296638710K043573DYNAGRAFT II DENTALNUN2005-07-29
2237271296638710K043573DYNAGRAFT II DENTALNUN2005-07-29
677871352300493K042730CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0GLYC2005-02-14
2237231352300493K042730CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0GLYC2005-02-14
2237271352300493K042730CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0GLYC2005-02-14
677872059731994K041324CALMATRIX CALCIUM SULFATE BONE GRAFT BINDERLYC2004-07-19
2237232059731994K041324CALMATRIX CALCIUM SULFATE BONE GRAFT BINDERLYC2004-07-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE1012024-07-09
NHA162022-08-10
NUN92006-03-29
LYC92005-02-14
ELL32006-05-22
LLZ12007-07-11
LZK11996-06-28

PMN#

GUDID#

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