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
- K250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive2Cleared 510(K)
- K242537BracePaste Fluoride Sealant2Cleared 510(K)
- K2340433M™ Transbond™ Orthodontic Adhesive2Cleared 510(K)
- K231817AlignerFlow LC2Cleared 510(K)
- K214054TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant2085202Cleared 510(K)
- K210115FiteBac CC OrthoSeal2Cleared 510(K)
- K202276BracePaste Band and Build LC2Cleared 510(K)
- K192682Orthocem, Ortho Bite2Cleared 510(K)
- K193388GlassLok Kits, GlassLok Powder, GlassLok Liquid2Cleared 510(K)
- K183147BrackFix2Cleared 510(K)
- K173020OBA-MCP, Orthodontic Bracket Adhesive with MCP2Cleared 510(K)
- K160782BracePaste Adhesive2Cleared 510(K)
- K161684Quantum LB2Cleared 510(K)
- K150128GC Ortho Connect, GC Ortho Etching Gel2Cleared 510(K)
- K143667GC KommonBase2Cleared 510(K)
- K142886DMRC Self-Cure Bracket Adhesive One Step and Primer2Cleared 510(K)
- K142881DMRC Dual Cure Orthodontic Band Cement2Cleared 510(K)
- K142880DMRC Light Cure Orthodontic Adhesive System2Cleared 510(K)
- K123348CLEAR ALIGNER ADHESIVE2Cleared 510(K)
- K120619ORTHODONTIC FLOWABLE BRACKET ADHESIVE2Cleared 510(K)
- K113401ORTHO-1(NOT FINALIZED)2Cleared 510(K)
- K113197APC FLASH-FREE ADHESIVE2Cleared 510(K)
- K111814PADLOCK2Cleared 510(K)
- K111696OPAL BAND CEMENT2Cleared 510(K)
- K101951LIGHT CURE RETAINER2Cleared 510(K)
- K100536TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE2Cleared 510(K)
- K100301OPAL BOND FLOW2Cleared 510(K)
- K094006OPAL BOND MV2Cleared 510(K)
- K093221PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II2Cleared 510(K)
- K090355OPAL SEAL2Cleared 510(K)
- K083051FLOWTAIN & FLOWTAIN LV2Cleared 510(K)
- K080445LION SE ONE STEP ORTHODONTIC ADHESIVE2Cleared 510(K)
- K080724GC OPB-1002Cleared 510(K)
- K081291PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION2Cleared 510(K)
- K073697TRANSBOND SUPREME ADHESIVE2Cleared 510(K)
- K073588GC MODELS OPA-100 AND JC-502Cleared 510(K)
- K072978TENDER ORTHO BOND-ENA BOND-ENA ETCH2Cleared 510(K)
- K072830RM BOND, MODEL J0322Cleared 510(K)
- K071590THERMA-CURE2Cleared 510(K)
- K061252PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM2Cleared 510(K)
- K061481GRENGLOO2Cleared 510(K)
- K053379RELI-ON ONE STEP, ORTHODONTIC ADHESIVE2Cleared 510(K)
- K050750LC BRACKET ADHESIVE SYSTEM2Cleared 510(K)
- K042422D3 CHROMA2Cleared 510(K)
- K040375IDEAL 1 ORTHODONTIC BAND CEMENT2Cleared 510(K)
- K040547AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE2Cleared 510(K)
- K040548AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE2Cleared 510(K)
- K033703IDEAL 1 ORTHODONTIC BRACKET ADHESIVE2Cleared 510(K)
- K033551EVOLVE2Cleared 510(K)
- K030644CONTEC DUO, CONTEC LC, CONTEC LCR2Cleared 510(K)
- K032195DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT2Cleared 510(K)
- K032407OPTIBAND LC2Cleared 510(K)
- K032042ENVISION2Cleared 510(K)
- K030977DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE2Cleared 510(K)
- K030980DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE2Cleared 510(K)
- K031420S & C -BRACKET ADHESIVES2Cleared 510(K)
- K030036TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT2Cleared 510(K)
- K022224COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM2Cleared 510(K)
- K020648GRIDLOCK 195 ADHESIVE2Cleared 510(K)
- K020502SOLO ORTHO 32Cleared 510(K)
- K020578GC FUJI ORTHO BAND PASTE PAK2Cleared 510(K)
- K020394APC PLUS ADHESIVE2Cleared 510(K)
- K014133PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE2Cleared 510(K)
- K014138PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT2Cleared 510(K)
- K020115PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM2Cleared 510(K)
- K014142UNITE BONDING ADHESIVE2Cleared 510(K)
- K014059PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE2Cleared 510(K)
- K012673PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM2Cleared 510(K)
- K012032FIRST SPEP2Cleared 510(K)
- K010544VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE2Cleared 510(K)
- K011521ORTHO VLC; ORTHO VLC CAPSULE2Cleared 510(K)
- K001881IMPROVED ENLIGHT LV2Cleared 510(K)
- K001446LIGHT-CURED ORTHODONTIC BAND CEMENT2Cleared 510(K)
- K001048LIGHT BOND (QUICK CURE)2Cleared 510(K)
- K994309SOLO ORTHO 22Cleared 510(K)
- K990743SOLO ORTHO2Cleared 510(K)
- K981036SMARTBOND2Cleared 510(K)
- K990252SOLO PLUS ORTHO2Cleared 510(K)
- K984362ENLIGHT LV2Cleared 510(K)
- K984217ENLIGHT-22Cleared 510(K)
- K981461GC FUJI ORTHO LC2Cleared 510(K)
- K972890ENLIGHT (TENTATIVE NAME)2Cleared 510(K)
- K962946ORTHO-ONE2Cleared 510(K)
- K961417GC FUJI ORTHO2Cleared 510(K)
- K955329RESILIENCE M5 PROTECTION PLUS2Cleared 510(K)
- K954374AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM2Cleared 510(K)
- K954373AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE2Cleared 510(K)
- K954372AMERICAN DENTAL PRODUCTS TWO PASTE ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE2Cleared 510(K)
- K954333AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM2Cleared 510(K)
- K954244AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM W/FLUORIDE2Cleared 510(K)
- K952856LIGHT-CURE PC2Cleared 510(K)
- K952855PC-LOCK2Cleared 510(K)
- K952857PRO-LOCK2Cleared 510(K)
- K952858LIGHT-CURE2Cleared 510(K)
- K953217PULPDENT TOUCHDOWN2Cleared 510(K)
- K952854PULPDENT GLASS IONOMER CEMENTS2Cleared 510(K)
- K952643RIGHT-ON ADHESIVE BOUDING SYSTEM2Cleared 510(K)
- K951380VILA PC2Cleared 510(K)
- K951381VILA2Cleared 510(K)
- K951235GIROC2Cleared 510(K)
- K951236PRO-LOCK2Cleared 510(K)
- K950556FUJI ORTHO LC2Cleared 510(K)
- K950514TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT2Cleared 510(K)
- K950512AMERICAN DENTAL PRODUCTS (ADP), FLUORIDE RELEASING GLASS IONOMER BAND CEMENT2Cleared 510(K)
- K946255THERMASET2Cleared 510(K)
- K942742ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV2Cleared 510(K)
- K942727ALPHA BOUND-RITE I NO-MIX ADHESIVE OR BOND-RITE I NO-MIX ADHESIVE2Cleared 510(K)
- K935625ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE2Cleared 510(K)
- K941015ORMCO SYSTEM 1+ (TM)2Cleared 510(K)
- K940845SYSTEM 12Cleared 510(K)
- K935714CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE2Cleared 510(K)
- K925359RESILIENCE ORTHODONTIC BRACKET ADHES W/BOND RESINS2Cleared 510(K)
- K930614ALPHA-DENT ORTHODONTIC ADHES TWO-PASTE BOND SYST2Cleared 510(K)
- K921283ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN2Cleared 510(K)
- K921044ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BOND2Cleared 510(K)
- K923399CHALLENGE II - PASTE ADHESIVE2Cleared 510(K)
- K921245THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II2Cleared 510(K)
- K921385IMPROVED SEQUENCE LIGHT CURE ADHESIVE2Cleared 510(K)
- K920781FLASH BOND2Cleared 510(K)
- K920534PORCELAIN PRIMER2Cleared 510(K)
- K914317ORTHODONTIC BRACKET ADHESIVE RESIN MATERIAL2Cleared 510(K)
- K914727SEQUENCE LIGHT CURE ADHESIVE2Cleared 510(K)
- K913854ORTHO LIGHT CURE2Cleared 510(K)
- K911286PULPDENT ORTHODONTIC BRACKET ADHESIVE2Cleared 510(K)
- K911271ADHESIVE PRECOATED BRACKETS2Cleared 510(K)
- K904090ORTHODONTIC BONDING ADHESIVE CONTROL2Cleared 510(K)
- K910803ENAMEL ETCHING GEL2Cleared 510(K)
- K895523PHASE II ORTHODONTIC ADHESIVE2Cleared 510(K)
- K895521RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE)2Cleared 510(K)
- K895522LIGHT BOND PASTE W/FLUORIDE2Cleared 510(K)
- K895163FORCE II2Cleared 510(K)
- K894639SKYROCK AND LIGHT SUPERBOND2Cleared 510(K)
- K894565LIGHT BOND SEALANT WITH FLUORIDE2Cleared 510(K)
- K894566MAXIMUM CURE SEALANT WITH FLUORIDE2Cleared 510(K)
- K893396AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM2Cleared 510(K)
- K893255SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVE2Cleared 510(K)
- K893037NO-MIX 30 ORTHODONTIC BONDING SYSTEMS2Cleared 510(K)
- K891464RESILIENCE C2, RESILIENCE L3 & RESILIENCE P42Cleared 510(K)
- K890834NO-MIX 30 ORTHODONTIC BONDING SYSTEM, PLASTIC2Cleared 510(K)
- K890740FRS LITE FLUORIDE RELEASING SEALANT2Cleared 510(K)
- K884575MAXIBOND2Cleared 510(K)
- K883465ORTHO-SEAL2Cleared 510(K)
- K880562ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT2Cleared 510(K)
- K880793LIGHT BOND2Cleared 510(K)
- K880791MAXIMUM CURE SEALANT2Cleared 510(K)
- K880766RELIANCE METAL PRIMER2Cleared 510(K)
- K880790PORCELAIN PRIMER2Cleared 510(K)
- K880792PLASTIC PRIMER2Cleared 510(K)
- K880393TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE2Cleared 510(K)
- K874228BOND FAST NO MIX ADHESIVE2Cleared 510(K)
- K875142PHASE II2Cleared 510(K)
- K875143RELY-A-BOND(NO MIX ORTHODONTIC ADHESIVE)2Cleared 510(K)
- K875144EXCEL FAST SET2Cleared 510(K)
- K875141EXCEL REGULAR SET2Cleared 510(K)
- K871591ORMCO GEL-ETCH2Cleared 510(K)
- K863709CHALLENGE ORTHODONTIC BONDING ADHESIVE2Cleared 510(K)
- K864008ACCLAIM* BRACKET ADHESIVE2Cleared 510(K)
- K861118ORTHOJOIN, ORTHODONTIC ADHESIVE2Cleared 510(K)
- K861258PERMABAND (ORTHODONTIC ADHESIVE)2Cleared 510(K)
- K860959DEPENDABOND2Cleared 510(K)
- K844844ESPE NIMETIC-GRIP2Cleared 510(K)
- K854050EXCEL BRACKET ADHESIVE2Cleared 510(K)
- K853523VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE2Cleared 510(K)
- K844133CLEANSE N BOND I2Cleared 510(K)
- K844134CLEANSE N BOND II2Cleared 510(K)
- K843527ORTHOMITE 111 ADHESIVE2Cleared 510(K)
- K842448BOSWORTH SUPER BOND DENTAL ADHESIVE2Cleared 510(K)
- K832292SOLO-TACH2Cleared 510(K)
- K832291AUTO-TACH2Cleared 510(K)
- K832112NO-MIX 30 ORTHODONTIC BONDING SYSTEM2Cleared 510(K)
- K831495CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHO2Cleared 510(K)
- K823928TOOTH CONDITIONER2Cleared 510(K)
- K823409HELIOSIT-ORTHODONTIC2Cleared 510(K)
- K823851ORTHODAPTIC* BONDING ADHESIVE2Cleared 510(K)
- K820092SECURE-ON-TOUCH2Cleared 510(K)
- K812547BEAUBON2Cleared 510(K)
- K810959SECURE2Cleared 510(K)
- K810715SECURE2Cleared 510(K)
- K810517INSTA-BOND2Cleared 510(K)
- K810241CRYSTAL-BOND2Cleared 510(K)
- K810210MAGIC-TOUCH2Cleared 510(K)
- K800392BRACKET BONDING SYSTEM METAL & PLASTIC2Cleared 510(K)
- K7920031 STEP2Cleared 510(K)
- K791132SCI-PHARM ORTHODONTIC ADHESIVE2Cleared 510(K)
- K790962SEAL & BOND DIRECT BONDING ORTHODONTIC2Cleared 510(K)
- K780334ADHESIVE, BRACKET AND CONDITIONER RESIN2Cleared 510(K)
- K780028ORTHODONTIC. PLASTIC BRACKET PRIMER2Cleared 510(K)
- K772126TEMP. BRIDGE, POSTERIOR 3-UNIT2Cleared 510(K)
- K771883REPLICA ACID-ETCH2Cleared 510(K)
- K771076ORTHODONTIC BRACKET ADHESIVE2Cleared 510(K)
- K760378CEMENT, RESIN DENTAL (AUTO-TACH)2Cleared 510(K)
- K760376CEMENT, RESIN DENTAL (SOLO-TACH)2Cleared 510(K)
- 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
- 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
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SMARTBOND
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K981036
- 510(k) Type
- Traditional
- Applicant
- GAC INTL., INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/5/1999
- Days to Decision
- 382 days
- Submission Type
- Statement