Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- DZSCapsule, Dental, Amalgam1Product Code
- DYHAdhesive, Bracket And Tooth Conditioner, Resin2Product Code
- DZEImplant, Endosseous, Root-Form2Product Code
- EBCSealant, Pit And Fissure, And Conditioner2Product Code
- EBDCoating, Filling Material, Resin2Product Code
- EBECoating, Denture Hydrophilic, Resin2Product Code
- EBFMaterial, Tooth Shade, Resin2Product Code
- EBGCrown And Bridge, Temporary, Resin2Product Code
- EBHMaterial, Impression Tray, Resin1Product Code
- EBIResin, Denture, Relining, Repairing, Rebasing2Product Code
- EBLPin, Retentive And Splinting, And Accessory Instruments1Product Code
- EBODenture Repair Kit2Product Code
- EBPReliner, Denture, Over The Counter2Product Code
- EFDAmalgamator, Dental, Ac-Powered1Product Code
- EFTCleanser, Denture, Over The Counter1Product Code
- EGGAttachment, Precision, All1Product Code
- EHEDispenser, Mercury And/Or Alloy1Product Code
- EHOBar, Preformed1Product Code
- EHPClasp, Preformed1Product Code
- EHQCusp, Preformed1Product Code
- EHRPad, Denture, Over The Counter2Product Code
- EHSCushion, Denture, Over The Counter2Product Code
- EITApplicator, Rapid Wax, Dental2Product Code
- EJHAlloy, Metal, Base2Product Code
- EJJAlloy, Amalgam2Product Code
- EJKLiner, Cavity, Calcium Hydroxide2Product Code
- EJLBur, Dental1Product Code
- EJPArticulators1Product Code
- EJSAlloy, Other Noble Metal2Product Code
- EJTAlloy, Gold-Based Noble Metal2Product Code
- EJWClasp, Wire1Product Code
- EJXAnchor, Preformed1Product Code
- EKLPoint, Silver, Endodontic1Product Code
- EKMGutta-Percha1Product Code
- EKNPoint, Paper, Endodontic1Product Code
- EKODenture Preformed (Partially Prefabricated Denture)2Product Code
- ELEImplant, Subperiosteal2Product Code
- ELJTeeth, Artificial, Posterior With Metal Insert1Product Code
- ELKTeeth, Artificial, Backing And Facing1Product Code
- ELLTeeth, Porcelain2Product Code
- ELMDenture, Plastic, Teeth2Product Code
- ELNTeeth, Preformed Gold Denture1Product Code
- ELOCusp, Gold And Stainless Steel1Product Code
- ELRPost, Root Canal1Product Code
- ELSSplint, Endodontic Stabilizing2Product Code
- ELWMaterial, Impression2Product Code
- ELYMercury2Product Code
- ELZCrown, Preformed1Product Code
- EMACement, Dental2Product Code
- EMBZinc Oxide Eugenol1Product Code
- JERCleaner, Denture, Mechanical1Product Code
- KCRFacebow1Product Code
- KCSPantograph1Product Code
- KIFResin, Root Canal Filling2Product Code
- KLEAgent, Tooth Bonding, Resin2Product Code
- KOLAdhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer1Product Code
- KOMAdhesive, Denture, Acacia And Karaya With Sodium Borate1Product Code
- KONAdhesive, Denture, Polyacrylamide Polymer (Modified Cationic)3Product Code
- KOOAdhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt1Product Code
- KOPAdhesive, Denture, Karaya1Product Code
- KOQAdhesive, Denture, Carboxymethylcellulose Sodium (40-100&)1Product Code
- KORAdhesive, Denture, Karaya With Sodium Borate3Product Code
- KOSAdhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer3Product Code
- KOTCarboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium1Product Code
- KXRApplicator, Resin1Product Code
- KXWAdhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer1Product Code
- KXXAdhesive, Denture, Karaya And Ethylene-Oxide Homopolymer1Product Code
- KXYPolyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce3Product Code
- KZNScanner, Color2Product Code
- KZOInk, Arch Tracing1Product Code
- KZPSolution, Cement Dissolving2Product Code
- LBHVarnish, Cavity2Product Code
- LPKBone Grafting Material, For Dental Bone Repair2Product Code
- LYCBone Grafting Material, Synthetic2Product Code
- K244006FG Bone Graft M2Cleared 510(K)
- K243745FG Bone Graft B2Cleared 510(K)
- K241186Synthetic Bone Graft Particulate2Cleared 510(K)
- K213260CMFlexTM2Cleared 510(K)
- K202675InRoad® Dental Synthetic Bone Graft2Cleared 510(K)
- K201546OsOpia Synthetic Bone Void Filler2Cleared 510(K)
- K201051Straumann BoneCeramic2Cleared 510(K)
- K192597Cytrans Granules2Cleared 510(K)
- K153676OSTEON III2Cleared 510(K)
- K153230ShefaBone SCPC Resorbable Bone Graft2Cleared 510(K)
- K140374MASTERGRAFT PUTTY2Cleared 510(K)
- K121177BOND APATITE2Cleared 510(K)
- K131385EASY-GRAFT2Cleared 510(K)
- K111105CURASAN OSSEOLIVE DENTAL2Cleared 510(K)
- K113282CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO2Cleared 510(K)
- K122240BONE PLUS BCP EAGLE EYE2Cleared 510(K)
- K113049SOCKET GRAFT2Cleared 510(K)
- K112716OSTEON II2Cleared 510(K)
- K110198BLUE SKY BIO TCP2Cleared 510(K)
- K112428NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT2Cleared 510(K)
- K111087FOUNDATION2Cleared 510(K)
- K103820REPROBONE DENTAL GRAFTING MATERIAL2Cleared 510(K)
- K110449ENDOBON XENOGRAFT GRANULES2Cleared 510(K)
- K102208NANOGEN2Cleared 510(K)
- K101827OSTEOSCAF2Cleared 510(K)
- K103709CERACELL DENTAL2Cleared 510(K)
- K102872OSBONE DENTAL2Cleared 510(K)
- K100883CARRIGEN2Cleared 510(K)
- K102812GAMMA-BSM; BETA-BSM; EQUIVABONE2Cleared 510(K)
- K102015OSTEON, OSTEON SINUS, OSTEON LIFTING2Cleared 510(K)
- K101718OSSEOCONDUCT2Cleared 510(K)
- K101014BOND BONE2Cleared 510(K)
- K091618VITOMATRIX2Cleared 510(K)
- K101426CEROS TCP GRANULES2Cleared 510(K)
- K090950BONE PLUS BCP2Cleared 510(K)
- K092194POLYBONE DENTAL2Cleared 510(K)
- K093390HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 60252Cleared 510(K)
- K093871PERIOPHIL B-TCP2Cleared 510(K)
- K100671NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT2Cleared 510(K)
- K093122MBCP+2Cleared 510(K)
- K092087MEDTRONIC DENTAL TCP2Cleared 510(K)
- K091729ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE2Cleared 510(K)
- K092788PERIOPHIL BIPHASIC2Cleared 510(K)
- K083372ARROWBONE-A, ARROWBONE-B2Cleared 510(K)
- K092567MODIFICATION TO UNIGRAFT2Cleared 510(K)
- K090850ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K091484NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT2Cleared 510(K)
- K090793BONGROS HA2Cleared 510(K)
- K090083CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-0902Cleared 510(K)
- K083858BOND BONE2Cleared 510(K)
- K083005NANGEL2Cleared 510(K)
- K082286BIOACTYS2Cleared 510(K)
- K083742SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX2Cleared 510(K)
- K082917MASTERGRAFT RESORBABLE CERAMIC GRANULES2Cleared 510(K)
- K081784MASTERGRAFT PUTTY2Cleared 510(K)
- K082383FORTOSS VITAL2Cleared 510(K)
- K081432HEALOS II BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K081721TRICOS A RESORBABLE SUBSTITUTE2Cleared 510(K)
- K081561OSFERION D2Cleared 510(K)
- K080772BONEMEDIK-DM2Cleared 510(K)
- K080308BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD2Cleared 510(K)
- K073571TRICOS T RESORBABLE BONE SUBSTITUTE2Cleared 510(K)
- K072397SYNOSS SYNTHETIC BONE GRAFT MATERIAL2Cleared 510(K)
- K071817OSTEOGRAF/N-3002Cleared 510(K)
- K072052OSTEOGRAF/D-3002Cleared 510(K)
- K072056OSTEOGRAF/D-7002Cleared 510(K)
- K072057OSTEOGRAF/LD-3002Cleared 510(K)
- K072058MODIFICATION TO: OSTEOGRAF/N-7002Cleared 510(K)
- K070784INION BIORESTORE2Cleared 510(K)
- K070055BONALIVE GRANULES AND BONALIVE PLATES2Cleared 510(K)
- K063634RTR SYRINGE2Cleared 510(K)
- K062834OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG40502Cleared 510(K)
- K062102ODONCER2Cleared 510(K)
- K063596PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL2Cleared 510(K)
- K063549NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT2Cleared 510(K)
- K063010REGEN BIOCEMENT2Cleared 510(K)
- K052493SOCKET GRAFT2Cleared 510(K)
- K060732MBCP GEL2Cleared 510(K)
- K060285BONEGEN - TR2Cleared 510(K)
- K053374OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM)2Cleared 510(K)
- K053387PERIOGLAS BONE GRAFT PARTICULATE2Cleared 510(K)
- K053022SYNTHES (USA) CHRONOS-BETA-TCP2Cleared 510(K)
- K051885MBCP2Cleared 510(K)
- K051091SYNTHOGRAFT2Cleared 510(K)
- K050170FORTOSS VITAL BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K050984BIOPLANT2Cleared 510(K)
- K051443CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO2Cleared 510(K)
- K042583CALC-I-OSS2Cleared 510(K)
- K051381ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE2Cleared 510(K)
- K050260BIORESORB MACRO PORE2Cleared 510(K)
- K042730CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G2Cleared 510(K)
- K030052OSTIM2Cleared 510(K)
- K042706OSSATURA DENTAL2Cleared 510(K)
- K040783FOUNDATION2Cleared 510(K)
- K031813OSSATURA DENTAL2Cleared 510(K)
- K041324CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER2Cleared 510(K)
- K030195BBP BONE SUBSTITUTES2Cleared 510(K)
- K040646STRAUMANN GRANULES2Cleared 510(K)
- K033098OSTEOGEN SBRG2Cleared 510(K)
- K033994NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K033729COLLAGEN DENTAL WOUND DRESSINGS2Cleared 510(K)
- K040278PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K033110C-GRAFT2Cleared 510(K)
- K031073PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K030682CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-32Cleared 510(K)
- K023998THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTE2Cleared 510(K)
- K023799FRIOS ALGIPORE2Cleared 510(K)
- K020720OSSIFORM2Cleared 510(K)
- K020396BIOCELLECT -PERIO2Cleared 510(K)
- K014289ORTHOSS RESORBABLE BONE VOID FILLER2Cleared 510(K)
- K013346GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE2Cleared 510(K)
- K012144CYTOFLEX2Cleared 510(K)
- K0120473I CALCIUM SULFATE BONE CEMENT2Cleared 510(K)
- K011403SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE2Cleared 510(K)
- K011032SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA2Cleared 510(K)
- K010775BIOCELLECT2Cleared 510(K)
- K010701MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER2Cleared 510(K)
- K003494MIMIX BONE REPLACEMENT SYSTEM2Cleared 510(K)
- K010320MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM2Cleared 510(K)
- K0034933I CALCIUM SODIUM PHOSPHATE BONE CEMENT2Cleared 510(K)
- K003286SYMPHONY GRAFT DELIVERY SYSTEM2Cleared 510(K)
- K003457UNIGRAFT2Cleared 510(K)
- K994137ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE2Cleared 510(K)
- K001598BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION2Cleared 510(K)
- K970569BIO-BLOCKS2Cleared 510(K)
- K000633SYNTHETIC GLASS BONE GRAFT MATERIAL2Cleared 510(K)
- K993610CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-2502Cleared 510(K)
- K000149NOVABONE-BIOGLASS BONE GRAFT PARTICULATE2Cleared 510(K)
- K993784UNIGRAFT2Cleared 510(K)
- K993238FORTOSS-CEMA2Cleared 510(K)
- K990537OSTEO-PIN MEMBRANE FIXATION PIN2Cleared 510(K)
- K992416PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE2Cleared 510(K)
- K992216BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE2Cleared 510(K)
- K983104NORIAN PERIODONTAL/DENTAL CEMENT (PDC)2Cleared 510(K)
- K982699UNIGRAFE2Cleared 510(K)
- K974399BIO-OSS COLLAGEN2Cleared 510(K)
- K970321BIO-OSS ANORGANIC BOVINE BONE2Cleared 510(K)
- K972817RESOR-PIN RESORBABLE MEMBRANE PIN2Cleared 510(K)
- K981182OSTEOGRAF/N-3002Cleared 510(K)
- K981214OSTEOGRAF/N-7002Cleared 510(K)
- K980679ENDOBON2Cleared 510(K)
- K973594GORE RESOLUT XT REGENERATIVE MATERIAL2Cleared 510(K)
- K972842INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE2Cleared 510(K)
- K972278CYTOPLAST REGENTEX TITANIUM 2502Cleared 510(K)
- K962548BSM BONE SUBSTITUTE MATERIAL KIT2Cleared 510(K)
- K970884RESOLUT REGENERATIVE MATERIAL2Cleared 510(K)
- K964342CYTOPLAST GBR2Cleared 510(K)
- K960267TBM SPONGE2Cleared 510(K)
- K940643OSMED EPI-GUIDE2Cleared 510(K)
- K962624RESOLUT REGENERATIVE MATERIAL2Cleared 510(K)
- K962494PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE2Cleared 510(K)
- K962838PERMARIDGE SYRINGE2Cleared 510(K)
- K962786OSTEOGRAF STAINLESS STEEL SYRING2Cleared 510(K)
- K960348OSTEOGRAF/N-300 HYDROXYLAPATITE2Cleared 510(K)
- K960368OSTEOGRAFT/N-700 HYDROXYLAPTITE2Cleared 510(K)
- K960353OSTEOGRAF/LD-300 HYDROXYLAPATITE2Cleared 510(K)
- K960361PERMAMESH-D HYDROXYLAPATITE MATRIX2Cleared 510(K)
- K960164BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 61402Cleared 510(K)
- K950306IMTEC BIOBARRIER2Cleared 510(K)
- K955096CAPSET CALCIUM SULFATE BONE GRAFT PLASTER2Cleared 510(K)
- K954763BIO-INTERFACES, INC,. BII-PLAST2Cleared 510(K)
- K954631OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE2Cleared 510(K)
- K952922BIOGRAN BIOACTIVE GLASS SYNTHETIC BONE GRAFT MATERIAL2Cleared 510(K)
- K952619BIO-OSS CERAMIC2Cleared 510(K)
- K952618BIO-OSS2Cleared 510(K)
- K950598BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFT2Cleared 510(K)
- K924408COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE2Cleared 510(K)
- K952617BIO-OSS2Cleared 510(K)
- K923310OSTEOGEN (HA RESORB)2Cleared 510(K)
- K950567BIO-APATITE 6140 HA PARTICLES2Cleared 510(K)
- K950511BLL-FIL 6140 PARTICLES2Cleared 510(K)
- K943186CAPSET CALCIUM SULFATE BONE GRAFT PLASTER2Cleared 510(K)
- K950165INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS2Cleared 510(K)
- K932866RESOLUT REGENERATIVE MATERIAL2Cleared 510(K)
- K941780ORTHOVITA BIOGRAN2Cleared 510(K)
- K942946OSTEOGRAF/D-100 HYDROXYLAPATITE2Cleared 510(K)
- K942212OSTEOGRAF/LD-300 HYDROXYLAPATITE2Cleared 510(K)
- K934049BII-PORE(TM) CANAL WALL PROSTHESIS2Cleared 510(K)
- K933688BII-PORE2Cleared 510(K)
- K934430BON APATITE HA PARTICLES2Cleared 510(K)
- K934947BII-PLAST2Cleared 510(K)
- K930115PERIOGLASS2Cleared 510(K)
- K924287710 POROUS HA PARTICLES-BII-PORE2Cleared 510(K)
- K924288B1018 POROUS HA BII-PORE2Cleared 510(K)
- K9242864060 POROUS HA PARTICULES BII PORE2Cleared 510(K)
- K922487BIO-INTERFACES 1840 POROUS HA PARTICLES-BII-PORE2Cleared 510(K)
- K9217761840 HA PARTICLES2Cleared 510(K)
- K920508BIO-OSS BLOCKS2Cleared 510(K)
- K921468PERMAMESH HYDROXYLAPATITE MATRIX2Cleared 510(K)
- K921469OSTEOGRAF/N-700 NATURAL HYDROXYLAPATITE 18-40 MESH2Cleared 510(K)
- K910432HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER2Cleared 510(K)
- K900136CEROS 80 (HA)2Cleared 510(K)
- K902295OSTEOGRAF/N NATURAL HYDROXYLAPATITE, 40-60 MESH2Cleared 510(K)
- K891173OSTEOGRAF/P PERIODONTAL HYDROXYLAPATITE, 40-602Cleared 510(K)
- K8850674060 HA PARTICLES2Cleared 510(K)
- K880371BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER2Cleared 510(K)
- K882098DENTORIDGE(TM) HYDROXYYLAPATITE2Cleared 510(K)
- K873763BIO-OSS - CERAMIC PURE NATURAL HYDROXYAPATITE2Cleared 510(K)
- K871773BIO-OSS PURE NAT HYDROXYAPATITE ENDOSS IMPLANT2Cleared 510(K)
- K863237HYDROXYLAPATITE BONE GRAFT MATERIAL2Cleared 510(K)
- K863176ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+2Cleared 510(K)
- K862324OSTEOGRAF/AR AND OSTEOGRAF/AR+2Cleared 510(K)
- K862061OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-402Cleared 510(K)
- K861041ENHANCE2Cleared 510(K)
- K860983INTERPORE 200 POROUS HYDROXYAPATITE2Cleared 510(K)
- K861083OSTEOGRAF/AR+(PLUS) ALVEOLAR RID HYDROX 18-40 MESH2Cleared 510(K)
- K861084OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH2Cleared 510(K)
- K852766HA-1000 & HA-500 HYDROXYLAPATITE TOOTH ROOT SUBSTI2Cleared 510(K)
- K852199OSTEOGRAF 2040 OSTEOGRAF 40602Cleared 510(K)
- K852742OSTEOGRAF AR ALVEOLAR RIDGE HYDROXYLAPATITE 18-402Cleared 510(K)
- K852765HA-2000 HYDROXYLAPATITE2Cleared 510(K)
- K852682CALCITITE BONE GRAFT MAT/ORAL & MAXILLOFACIAL SURG2Cleared 510(K)
- K850012ALLOTROPAT/HEYLTEX CORP. BONE GRAFTING DENSE HYDRO2Cleared 510(K)
- K843398OSTEOGEN2Cleared 510(K)
- K842718HYDROXYAPATITE2Cleared 510(K)
- K843154TOOTH ROOT SOCKET GAUGE2Cleared 510(K)
- K843153ANTERIOR ALVEOLAR RIDGE SIZER2Cleared 510(K)
- K842163RIDGEMATRIX 20/40 MESH, PERIOMATRIX2Cleared 510(K)
- K841201POROUS HYDROXYAPATITE BG2002Cleared 510(K)
- K840260PERIOGRAF DURAPATITE 40-60 MESH2Cleared 510(K)
- K832509MBS HARD TISSUE REPLACEMENT SYSTEM2Cleared 510(K)
- K830304REPLAM HYDROXYAPATITE2Cleared 510(K)
- K821752SYNTHOGRAFT LG-AUGMENTATION & BONE FILL2Cleared 510(K)
- K820023CONAGRAF TM DURAPATITE CONES2Cleared 510(K)
- K813070PERIOGRAF2Cleared 510(K)
- K811101HYDROXYLAPATITE2Cleared 510(K)
- K810382HYDROXYLAPATITE ALVEOLAR RIDGE MAIN2Cleared 510(K)
- K791416PYROLITE CARBON ALVEOLAR MAINTEN IMPLANT2Cleared 510(K)
- LZDJoint, Temporomandibular, Implant3Product Code
- MMTResin, Root Canal Filling Containing Chloroform3Product Code
- MMUAdhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight3Product Code
- MPIGlenoid Fossa Prosthesis3Product Code
- MPJInterarticular Disc Prosthesis (Interpositional Implant)3Product Code
- MPLMandibular Condyle Prosthesis3Product Code
- MZWDental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief2Product Code
- NDPAccessories, Implant, Dental, Endosseous1Product Code
- NFEMaterials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation2Product Code
- NHAAbutment, Implant, Dental, Endosseous2Product Code
- NKJCushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter1Product Code
- NMEBur, Diamond Coated, Reprocessed1Product Code
- NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations2Product Code
- NPKBarrier, Synthetic, Intraoral2Product Code
- NPLBarrier, Animal Source, Intraoral2Product Code
- NPMBone Grafting Material, Animal Source2Product Code
- NPZBone Grafting Material, Dental, With Biologic Component3Product Code
- NQABiologic Material, Dental3Product Code
- NRQBlade-Form Endosseous Dental Implant2Product Code
- NUNBone Grafting Material, Human Source2Product Code
- NUXCleanser, Denture, Prescription1Product Code
- NYDEndodontic Kit2Product Code
- OATImplant, Endosseous, Orthodontic2Product Code
- NYEFixture Mount Kit1Product Code
- OFWRestorative Instrument And Component Tray2Product Code
- OFYDental Implant Surgical Tray1Product Code
- OIVDental Amalgam2Product Code
- PHRDiammine Silver Fluoride Dental Hypersensitivity Varnish2Product Code
- PMEExternal Cleaning Solution2Product Code
- PNPDental Abutment Design Software For Dental Laboratory2Product Code
- POWCrown And Bridge, Long-Term Temporary, Resin2Product Code
- PZYAdditively Manufactured, Preformed, Resin Denture Tooth2Product Code
- QJKIntraoral Camera2Product Code
- QRQNon-Irrigation Endosseous Dental Implant Drill Bits1Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
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OSTEON II
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K112716
- 510(k) Type
- Traditional
- Applicant
- GENOSS Co., Ltd.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/17/2012
- Days to Decision
- 120 days
- Submission Type
- Summary