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Dental

314 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
EMDOGAIN (P930021/S011)The Straumann Company2009-06-19
COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING (P840062/S019)Integra Lifesciences Corp.2009-06-09
COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING (P840062/S018)Integra Lifesciences Corp.2009-03-26
INFUSE BONE GRAFT (P050053/S011)Medtronic, Inc.2009-02-20
INFUSE BONE GRAFT (P050053/S006)Medtronic, Inc.2008-12-04
INFUSE BONE GRAFT (P050053/S009)Medtronic, Inc.2008-11-24
GEM 21S (GROWTH ENHANCED MATRIX) (P040013/S012)Lynch Biologics, LLC2008-09-03
GEM21S GROWTH FACTOR ENHANCED (P040013/S013)Lynch Biologics, LLC2008-08-29
INFUSE BONE GRAFT (P050053/S005)Medtronic, Inc.2008-08-15
INFUSE BONE GRAFT (P050053/S008)Medtronic, Inc.2008-05-13
COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING (P840062/S017)Integra Lifesciences Corp.2008-04-15
INFUSE BONE GRAFT (P050053/S001)Medtronic, Inc.2008-03-06
INFUSE BONE GRAFT (P050053/S007)Medtronic, Inc.2008-02-14
INFUSE BONE GRAFT (P050053/S004)Medtronic, Inc.2008-01-14
PEPGEN 15 (P990033/S015)Ceramed Corp.2008-01-11
EMODOGAIN (P930021/S010)The Straumann Company2007-11-28
COLLACOTE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P840062/S016)Integra Lifesciences Corp.2007-11-23
HELITAPE AND HELIPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY (P840062/S014)Integra Lifesciences Corp.2007-10-30
INFUSE BONE GRAFT (P050053/S002)Medtronic, Inc.2007-10-05
COLLACOTE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P840062/S015)Integra Lifesciences Corp.2007-10-03
GEM 21S GROWTH-FACTOR ENHANCED MATRIX (P040013/S011)Lynch Biologics, LLC2007-10-01
GEM 21S (GROWTH ENHANCED MATRIX) (P040013/S009)Lynch Biologics, LLC2007-08-10
PEPGEN P-15, PEPGEN P-15 FLOW & PEPGEN P-15 PUTTY (P990033/S014)Ceramed Corp.2007-08-09
COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING (P840062/S013)Integra Lifesciences Corp.2007-07-24
INFUSE BONE GRAFT (P050053)Medtronic, Inc.2007-03-09
COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING (P840062/S012)Integra Lifesciences Corp.2007-02-09
GEM 21S GROWTH FACTOR ENHANCED MATRIX RHPDGF-BB COMPONENT (P040013/S008)Lynch Biologics, LLC2006-11-17
COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING (P840062/S011)Integra Lifesciences Corp.2006-11-08
TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S002)Biomet Microfixation, Inc.2006-10-13
PEPGEN P-15 DENTAL BONE GRAFTING MATERIAL WITH BIOLOGIC COMPONENT (P990033/S008)Ceramed Corp.2006-10-05
GEM 21S (P040013/S003)Lynch Biologics, LLC2006-09-22
COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING (P840062/S009)Integra Lifesciences Corp.2006-09-20
GEM 21S GROWTH FACTOR ENHANCED MATRIX (P040013/S006)Lynch Biologics, LLC2006-09-08
GEM 21S GROWTH FACTOR ENHANCED MATRIX (P040013/S005)Lynch Biologics, LLC2006-08-21
GEM 21S GROWTH FACTOR ENHANCED MATRIX (P040013/S004)Lynch Biologics, LLC2006-07-17
PEPGEN P-15 DENTAL BONE GRAFTING MATERIAL AND BIOLOGIC COMPONENT (P990033/S007)Ceramed Corp.2006-06-06
TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S001)Biomet Microfixation, Inc.2006-05-26
EMDOGAIN (P930021/S009)The Straumann Company2006-04-24
GEM 21S GROWTH FACTOR ENCHANCED MATRIX (P040013/S002)Lynch Biologics, LLC2006-03-27
COLLACOTE ABSORABLE COLLAGEN WOUND DRESSING (P840062/S010)Integra Lifesciences Corp.2005-12-29
GEM 21S (GROWTH-FACTOR ENHANCED MATRIX (P040013)Lynch Biologics, LLC2005-11-18
WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016)Biomet Microfixation, Inc.2005-09-21
PEPGEN P-15, PEPGEN P-15 FLOW, AND PEPGEN P-15 PUTTY (P990033/S005)Ceramed Corp.2004-03-15
TMJ FOSSA EMINENCE/CONDYLAR PROSTHESIS SYSTEM (P000035/S003)Nexus CMF, LLC2004-01-22
TMJ FOSSA EMINENCE PROSTHESIS SYSTEM (P000023/S003)Nexus CMF, LLC2004-01-22
CERASORB DENTAL (P800035/S011)Curasan AG2003-12-08
EMDOGAIN GEL (P930021/S008)The Straumann Company2003-12-02
TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS (P000035/S004)Nexus CMF, LLC2003-10-14
TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS (P000023/S004)Nexus CMF, LLC2003-10-14
EMDOGAIN GEL (P930021/S007)The Straumann Company2003-05-20
COLLACOTE, COLLAPLUG, COLLATAPE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY (P840062/S008)Integra Lifesciences Corp.2003-05-16
EMDOGAIN GEL (P930021/S006)The Straumann Company2003-03-28
TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM (P980052/S002)Stryker Leibinger, GmbH & Co KG2003-01-14
CARISOLV MINIMAL INVASIVE DENTAL CARIES REMOVAL SYSTEM (P000005/S005)Rls Global AB2002-10-23
DRILAC CUBES AND GRANULES (P800012/S010)Osmed, Inc.2002-10-09
DRILAC CUBES AND GRANULES (P800012/S009)Osmed, Inc.2002-09-17
FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM AND FOSSA-EMINENCE PROSTHESIS SYSTEM (P000035/S002)Nexus CMF, LLC2002-09-12
FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM AND FOSSA-EMINENCE PROSTHESIS SYSTEM (P000023/S001)Nexus CMF, LLC2002-09-12
FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM AND FOSSA-EMINENCE PROSTHESIS SYSTEM (P000035/S001)Nexus CMF, LLC2002-09-12
FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM AND FOSSA-EMINENCE PROSTHESIS SYSTEM (P000023/S002)Nexus CMF, LLC2002-09-12
PEPGEN P-15 AND PEPGEN P-15 FLOW (P990033/S004)Ceramed Corp.2002-06-14
EMDOGAIN GEL (P930021/S005)The Straumann Company2002-06-04
DRILAC GRANULES (P800012/S008)Osmed, Inc.2002-03-05
TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM (P980052/S001)Stryker Leibinger, GmbH & Co KG2002-03-01
CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM (P000005/S001)Rls Global AB2002-02-05
PEPGEN P-15/PEPGEN P-15 FLOW (P990033/S003)Ceramed Corp.2002-01-25
PERI-OSS (P800035/S010)Curasan AG2001-10-04
PEPGEN P-15 FLOW (FORMERLY PEPGEN P-15 PUTTY) (P990033/S002)Ceramed Corp.2001-08-09
CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM (P000005)Rls Global AB2001-06-27
TMJ FOSSA-EMINENCE PROSTHESIS(TM) (P000035)Nexus CMF, LLC2001-02-27
EMDOGAIN (P930021/S004)The Straumann Company2001-01-19
TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES (P000023)Nexus CMF, LLC2001-01-05
HELICOTE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY (P840062/S007)Integra Lifesciences Corp.2000-12-07
PEPGEN-P15 (P990033/S001)Ceramed Corp.2000-01-27
PEPGEN P-15 (P990033)Ceramed Corp.1999-10-25
EMDOGAIN (P930021/S003)The Straumann Company1999-08-24
EMDOGAIN (P930021/S002)The Straumann Company1999-07-23
TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS (P980052)Stryker Leibinger, GmbH & Co KG1999-07-02
BIORA EMDOGAIN(R) (P930021/S001)The Straumann Company1999-05-18
BIORA EMDOGAIN(R) (P930021)The Straumann Company1996-09-30
COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS (P840062/S006)Integra Lifesciences Corp.1995-09-08
DRILAC{TM} CUBES / GRANULES (P800012/S006)Osmed, Inc.1994-06-28
COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS (P840062/S004)Integra Lifesciences Corp.1993-06-24
COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS (P840062/S003)Integra Lifesciences Corp.1992-03-27
COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS (P840062/S002)Integra Lifesciences Corp.1990-05-08
ALVEOFORM TM BIOGRAFT (P860012)Collagen Corp.1988-10-28
SALITRON SYSTEM (P860067)Biosonics, Inc.1988-05-17
CARIDEX(TM) REMOVAL SYSTEM (P830035/S003)Indevus Pharmaceuticals, Inc.1987-11-25
DRILAC{TM} CUBES (P800012/S002)Osmed, Inc.1987-01-29
DRILAC{TM} CUBES (P800012/S004)Osmed, Inc.1986-12-22
COLLACOTE(TM) (P840062/S001)Integra Lifesciences Corp.1986-03-13
COLLACOTE(TM) (P840062)Integra Lifesciences Corp.1985-11-08
CARIDEX(TM) REMOVAL SYSTEM (P830035/S002)Indevus Pharmaceuticals, Inc.1985-08-28
GK-101E CARIES REMOVAL AGENT/SYSTEM (P830035/S001)Indevus Pharmaceuticals, Inc.1985-04-18
SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) (P800035/S007)Curasan AG1984-08-07
GK-101E CARIES REMOVAL AGENT/SYSTEM (P830035)Indevus Pharmaceuticals, Inc.1984-07-06
AUGMEN(TM) AKA SYNTHOGRAFT(TM) LG (P800035/S008)Curasan AG1983-11-10
SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) (P800035/S004)Curasan AG1983-06-07
DRILAC CUBES{TM} (P800012)Osmed, Inc.1983-01-28
SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) (P800035/S003)Curasan AG1982-11-08
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