FDA Product Code
FDA Product Code LYC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3930
510(k) Clearances — 231 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K040646 | STRAUMANN GRANULES | The Straumann Co. | 2004-05-03 | Traditional | PDF ↗ |
| K033098 | OSTEOGEN SBRG | Impladent , Ltd. | 2004-04-27 | Traditional | PDF ↗ |
| K033994 | NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE | Novabone Products, LLC | 2004-03-25 | Traditional | PDF ↗ |
| K033729 | COLLAGEN DENTAL WOUND DRESSINGS | Collagen Matrix, Inc. | 2004-03-17 | Traditional | PDF ↗ |
| K040278 | PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE | Novabone Products, LLC | 2004-03-01 | Special | PDF ↗ |
| K033110 | C-GRAFT | The Clinician'S Preference, LLC | 2003-12-10 | Traditional | PDF ↗ |
| K031073 | PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE | Novabone Products, LLC | 2003-11-05 | Traditional | PDF ↗ |
| K030682 | CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3 | Bioform, Inc. | 2003-06-27 | Traditional | PDF ↗ |
| K023998 | THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTE | Therics, Inc. | 2003-03-26 | Traditional | PDF ↗ |
| K023799 | FRIOS ALGIPORE | Friadent GmbH | 2003-02-05 | Traditional | PDF ↗ |
| K020720 | OSSIFORM | Unicare Biomedical, Inc. | 2002-05-07 | Traditional | PDF ↗ |
| K020396 | BIOCELLECT -PERIO | Imtec Corp. | 2002-04-10 | Traditional | PDF ↗ |
| K014289 | ORTHOSS RESORBABLE BONE VOID FILLER | Geistlich-Pharma | 2002-03-28 | Traditional | PDF ↗ |
| K013346 | GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE | W. L. Gore & Associates, Inc. | 2001-12-19 | Traditional | PDF ↗ |
| K012144 | CYTOFLEX | Unicare Biomedical, Inc. | 2001-10-01 | Traditional | PDF ↗ |
| K012047 | 3I CALCIUM SULFATE BONE CEMENT | Implant Innovations, Inc. | 2001-09-19 | Traditional | PDF ↗ |
| K011403 | SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE | Orthogen Corp. | 2001-09-11 | Traditional | PDF ↗ |
| K011032 | SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA | Harvest Technologies, Corp. | 2001-07-03 | Traditional | PDF ↗ |
| K010775 | BIOCELLECT | Imtec Corp. | 2001-06-12 | Traditional | PDF ↗ |
| K010701 | MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER | Medtronic Sofamor Danek USA, Inc. | 2001-06-05 | Traditional | PDF ↗ |
| K003494 | MIMIX BONE REPLACEMENT SYSTEM | Biomet, Inc. | 2001-04-09 | Traditional | PDF ↗ |
| K010320 | MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM | Depuyacromed | 2001-03-01 | Special | PDF ↗ |
| K003493 | 3I CALCIUM SODIUM PHOSPHATE BONE CEMENT | Biomet, Inc. | 2001-02-09 | Traditional | PDF ↗ |
| K003286 | SYMPHONY GRAFT DELIVERY SYSTEM | Depuyacromed | 2001-01-18 | Traditional | PDF ↗ |
| K003457 | UNIGRAFT | Unicare Biomedical | 2001-01-09 | Traditional | PDF ↗ |
| K994137 | ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE | Atrix Laboratories, Inc. | 2000-09-13 | Traditional | PDF ↗ |
| K001598 | BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION | Col-Bar , Ltd. | 2000-08-22 | Traditional | PDF ↗ |
| K970569 | BIO-BLOCKS | Geistlich-Pharma | 2000-08-14 | Traditional | PDF ↗ |
| K000633 | SYNTHETIC GLASS BONE GRAFT MATERIAL | Blue Sky Bio | 2000-05-25 | Traditional | PDF ↗ |
| K993610 | CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250 | Osteogenics Biomedical, Inc. | 2000-03-02 | Traditional | PDF ↗ |
| K000149 | NOVABONE-BIOGLASS BONE GRAFT PARTICULATE | Usbiomaterials Corp. | 2000-02-07 | Special | PDF ↗ |
| K993784 | UNIGRAFT | Unicare Biomedical | 2000-01-27 | Traditional | PDF ↗ |
| K993238 | FORTOSS-CEMA | Biocomposites, Ltd. | 2000-01-14 | Traditional | PDF ↗ |
| K990537 | OSTEO-PIN MEMBRANE FIXATION PIN | Luitpold Pharmaceuticals, Inc. | 1999-11-19 | Traditional | PDF ↗ |
| K992416 | PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE | Usbiomaterials Corp. | 1999-10-15 | Traditional | PDF ↗ |
| K992216 | BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE | Integra Lifesciences Corp. | 1999-07-26 | Special | PDF ↗ |
| K983104 | NORIAN PERIODONTAL/DENTAL CEMENT (PDC) | Norian Corp. | 1999-02-12 | Traditional | PDF ↗ |
| K982699 | UNIGRAFE | Unicare Biomedical | 1998-10-20 | Traditional | PDF ↗ |
| K974399 | BIO-OSS COLLAGEN | Geistlich-Pharma | 1998-09-16 | Traditional | PDF ↗ |
| K970321 | BIO-OSS ANORGANIC BOVINE BONE | Geistlich-Pharma | 1998-09-15 | Traditional | PDF ↗ |
| K972817 | RESOR-PIN RESORBABLE MEMBRANE PIN | Geistlich-Pharma | 1998-07-24 | Traditional | PDF ↗ |
| K981182 | OSTEOGRAF/N-300 | Ceramed Dental, LLC | 1998-07-02 | Traditional | PDF ↗ |
| K981214 | OSTEOGRAF/N-700 | Ceramed Dental, LLC | 1998-06-26 | Traditional | PDF ↗ |
| K980679 | ENDOBON | Biomet, Inc. | 1998-04-03 | Traditional | PDF ↗ |
| K973594 | GORE RESOLUT XT REGENERATIVE MATERIAL | W. L. Gore & Associates, Inc. | 1997-12-17 | Traditional | PDF ↗ |
| K972842 | INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE | Interpore Intl. | 1997-10-30 | Traditional | PDF ↗ |
| K972278 | CYTOPLAST REGENTEX TITANIUM 250 | Osteogenics Co. | 1997-08-06 | Traditional | PDF ↗ |
| K962548 | BSM BONE SUBSTITUTE MATERIAL KIT | Etex Corp. | 1997-08-05 | Traditional | PDF ↗ |
| K970884 | RESOLUT REGENERATIVE MATERIAL | W. L. Gore & Associates, Inc. | 1997-05-08 | Traditional | PDF ↗ |
| K964342 | CYTOPLAST GBR | Osteogenics Co. | 1997-03-11 | Traditional | PDF ↗ |
| K960267 | TBM SPONGE | Biocoll Laboratories, Inc. | 1996-11-05 | Traditional | PDF ↗ |
| K940643 | OSMED EPI-GUIDE | Thm Biomedical, Inc. | 1996-10-15 | Traditional | PDF ↗ |
| K962624 | RESOLUT REGENERATIVE MATERIAL | W. L. Gore & Associates, Inc. | 1996-10-03 | Traditional | PDF ↗ |
| K962494 | PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE | Usbiomaterials Corp. | 1996-09-20 | Traditional | PDF ↗ |
| K962838 | PERMARIDGE SYRINGE | Ceramed Corp. | 1996-08-20 | Traditional | PDF ↗ |
| K962786 | OSTEOGRAF STAINLESS STEEL SYRING | Ceramed Corp. | 1996-08-01 | Traditional | PDF ↗ |
| K960348 | OSTEOGRAF/N-300 HYDROXYLAPATITE | Ceramed Corp. | 1996-04-22 | Traditional | PDF ↗ |
| K960353 | OSTEOGRAF/LD-300 HYDROXYLAPATITE | Ceramed Corp. | 1996-04-18 | Traditional | PDF ↗ |
| K960368 | OSTEOGRAFT/N-700 HYDROXYLAPTITE | Ceramed Corp. | 1996-04-18 | Traditional | PDF ↗ |
| K960361 | PERMAMESH-D HYDROXYLAPATITE MATRIX | Ceramed Corp. | 1996-04-15 | Traditional | PDF ↗ |
| K960164 | BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140 | Bio-Interfaces, Inc. | 1996-04-10 | Traditional | PDF ↗ |
| K950306 | IMTEC BIOBARRIER | Imtec Corp. | 1996-02-06 | Traditional | PDF ↗ |
| K955096 | CAPSET CALCIUM SULFATE BONE GRAFT PLASTER | Lifecore Biomedical, Inc. | 1996-01-23 | Traditional | PDF ↗ |
| K954763 | BIO-INTERFACES, INC,. BII-PLAST | Bio-Interfaces, Inc. | 1996-01-04 | Traditional | PDF ↗ |
| K954631 | OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE | Ceramed Corp. | 1996-01-02 | Traditional | PDF ↗ |
| K952922 | BIOGRAN BIOACTIVE GLASS SYNTHETIC BONE GRAFT MATERIAL | Orthovita Co. | 1995-12-19 | Traditional | PDF ↗ |
| K952619 | BIO-OSS CERAMIC | Geistlich-Pharma | 1995-08-28 | Traditional | PDF ↗ |
| K952618 | BIO-OSS | Geistlich-Pharma | 1995-08-28 | Traditional | PDF ↗ |
| K950598 | BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFT | Bio-Interfaces, Inc. | 1995-08-23 | Traditional | PDF ↗ |
| K924408 | COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE | Colla-Tec, Inc. | 1995-08-22 | Traditional | PDF ↗ |
| K952617 | BIO-OSS | Geistlich-Pharma | 1995-08-07 | Traditional | PDF ↗ |
| K923310 | OSTEOGEN (HA RESORB) | Impladent | 1995-05-31 | Traditional | PDF ↗ |
| K950567 | BIO-APATITE 6140 HA PARTICLES | Bio-Interfaces, Inc. | 1995-05-09 | Traditional | PDF ↗ |
| K950511 | BLL-FIL 6140 PARTICLES | Bio-Interfaces, Inc. | 1995-04-27 | Traditional | PDF ↗ |
| K943186 | CAPSET CALCIUM SULFATE BONE GRAFT PLASTER | Lifecore Biomedical, Inc. | 1995-04-10 | Traditional | PDF ↗ |
| K932866 | RESOLUT REGENERATIVE MATERIAL | W. L. Gore & Associates, Inc. | 1995-03-28 | Traditional | PDF ↗ |
| K950165 | INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS | Interpore Intl. | 1995-03-28 | Traditional | PDF ↗ |
| K941780 | ORTHOVITA BIOGRAN | Orthovita Co. | 1995-02-10 | Traditional | PDF ↗ |
| K942946 | OSTEOGRAF/D-100 HYDROXYLAPATITE | Ceramed Corp. | 1994-10-05 | Traditional | PDF ↗ |
| K942212 | OSTEOGRAF/LD-300 HYDROXYLAPATITE | Ceramed Corp. | 1994-08-23 | Traditional | PDF ↗ |
| K934049 | BII-PORE(TM) CANAL WALL PROSTHESIS | Bio-Interfaces, Inc. | 1994-07-19 | Traditional | PDF ↗ |
| K933688 | BII-PORE | Bio-Interfaces, Inc. | 1994-07-19 | Traditional | PDF ↗ |
| K934430 | BON APATITE HA PARTICLES | Bio-Interfaces, Inc. | 1994-05-18 | Traditional | PDF ↗ |
| K934947 | BII-PLAST | Bio-Interfaces, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K930115 | PERIOGLASS | Usbiomaterials Corp. | 1993-11-04 | Traditional | PDF ↗ |
| K924287 | 710 POROUS HA PARTICLES-BII-PORE | Bio-Interfaces, Inc. | 1993-04-30 | Traditional | PDF ↗ |
| K922487 | BIO-INTERFACES 1840 POROUS HA PARTICLES-BII-PORE | Bio-Interfaces, Inc. | 1993-04-14 | Traditional | PDF ↗ |
| K924286 | 4060 POROUS HA PARTICULES BII PORE | Bio-Interfaces, Inc. | 1993-04-14 | Traditional | PDF ↗ |
| K924288 | B1018 POROUS HA BII-PORE | Bio-Interfaces, Inc. | 1993-04-14 | Traditional | PDF ↗ |
| K921776 | 1840 HA PARTICLES | Bio-Interfaces, Inc. | 1992-12-04 | Traditional | PDF ↗ |
| K920508 | BIO-OSS BLOCKS | Geistlich-Pharma | 1992-11-24 | Traditional | PDF ↗ |
| K921468 | PERMAMESH HYDROXYLAPATITE MATRIX | Ceramed Corp. | 1992-08-21 | Traditional | PDF ↗ |
| K921469 | OSTEOGRAF/N-700 NATURAL HYDROXYLAPATITE 18-40 MESH | Ceramed Corp. | 1992-06-25 | Traditional | PDF ↗ |
| K910432 | HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER | Lifecore Biomedical, Inc. | 1991-05-01 | Traditional | PDF ↗ |
| K900136 | CEROS 80 (HA) | Mathys Corp. | 1991-01-29 | Traditional | PDF ↗ |
| K902295 | OSTEOGRAF/N NATURAL HYDROXYLAPATITE, 40-60 MESH | Ceramed Corp. | 1990-12-11 | Traditional | PDF ↗ |
| K891173 | OSTEOGRAF/P PERIODONTAL HYDROXYLAPATITE, 40-60 | Ceramed Corp. | 1989-09-01 | Traditional | PDF ↗ |
| K885067 | 4060 HA PARTICLES | Bio-Interfaces, Inc. | 1989-01-11 | Traditional | PDF ↗ |
| K880371 | BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER | American Biomaterials Corp. | 1988-11-18 | Traditional | PDF ↗ |
| K882098 | DENTORIDGE(TM) HYDROXYYLAPATITE | Norian Corp. | 1988-06-13 | Traditional | PDF ↗ |
Product code LYC · Class II · Dental. Data: openFDA.