Anesthesiology
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- 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
- K243254Parkell Pit and Fissure Sealant2Cleared 510(K)
- K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio2Cleared 510(K)
- K230455Enamel Coating Resin2Cleared 510(K)
- K190998BA Pit & Fissure Sealant2Cleared 510(K)
- K190339Helioseal F Plus2Cleared 510(K)
- K172169Pulpdent (Activa) Pit and Fissure Sealant with MCP2Cleared 510(K)
- K171330Nanova Sealant2Cleared 510(K)
- K162598HAPI Seal2Cleared 510(K)
- K161580Premier Sealant2Cleared 510(K)
- K141717PACSEAL PIT & FISSURE SEALANT2Cleared 510(K)
- K130485CONTROL SEAL2Cleared 510(K)
- K122521PREVENT SEAL2Cleared 510(K)
- K113818EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL2Cleared 510(K)
- K112517ULTRASEAL XT HYDRO2Cleared 510(K)
- K111782BEAUTISEALANT2Cleared 510(K)
- K110058BPA-FREE PIT AND FISSURE SEALANT2Cleared 510(K)
- K102252DMP PIT & FISSURE SEALANT2Cleared 510(K)
- K103121ECO-S2Cleared 510(K)
- K101245ULTRASEAL ID2Cleared 510(K)
- K100062INFILTRATION KIT2Cleared 510(K)
- K093059SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT2Cleared 510(K)
- K091635VENUS DIAMOND FLOW2Cleared 510(K)
- K091632SPK SEALANT2Cleared 510(K)
- K083473CLEAR BRAVO2Cleared 510(K)
- K081493INFILTRATION KIT2Cleared 510(K)
- K071158AURALAY PIT & FISSURE SEALANT2Cleared 510(K)
- K062886ASCENT PIT AND FISSURE SEALANT, MODEL 006-000192Cleared 510(K)
- K061997PREMIER SELF-ETCHING ENAMEL SEALANT2Cleared 510(K)
- K062344GRANDIO SEAL2Cleared 510(K)
- K061823ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE2Cleared 510(K)
- K052281EMBRACE WETBOND CLEAR SEALANT2Cleared 510(K)
- K053089ASCENT PIT & FISSURE SEALANT2Cleared 510(K)
- K051224BOSWORTH SEAL2Cleared 510(K)
- K050871RIVA PROTECT2Cleared 510(K)
- K050959DELTON ILLUMINATING PIT AND FISSURE SEALING2Cleared 510(K)
- K042823COSMEDENT PIT & FISSURE SEALANT2Cleared 510(K)
- K033751AEGIS PIT & FISSURE SEALANT WITH ACP2Cleared 510(K)
- K031811PIT & FISSURE SEALANT WITH FLUORIDE2Cleared 510(K)
- K021842ADMIRA SEAL2Cleared 510(K)
- K021844ADMIRA PROTECT2Cleared 510(K)
- K020287DENTITION INTEGRATING MATERIAL2Cleared 510(K)
- K012761PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT2Cleared 510(K)
- K012542REVOTEK LC2Cleared 510(K)
- K012742TEETHMATE F-12Cleared 510(K)
- K011908OPTIBOND SOLO PLUS 32Cleared 510(K)
- K011491HELIOSEAL CLEAR CHROMA2Cleared 510(K)
- K011822PIT AND FISSURE CHEMICAL CURING SEALANT2Cleared 510(K)
- K993846ULTRASEAL XT PLUS2Cleared 510(K)
- K992519NRC NON-RINSE CONDITIONER2Cleared 510(K)
- K9923263M CLINPRO SEALANT2Cleared 510(K)
- K992518PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM2Cleared 510(K)
- K992516DYRACT SEAL COMPOMER PIT & FISSURE SEALANT2Cleared 510(K)
- K991909DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT2Cleared 510(K)
- K991902LC PIT & FISSURE SEALANT2Cleared 510(K)
- K991099AMERICAN DENTAL PRODUCTS ETCH-DETECT2Cleared 510(K)
- K990650CONSEAL F2Cleared 510(K)
- K990306HYDRO-CAST DENTAL ETCHING GEL, MODEL 600252Cleared 510(K)
- K982564DELTON FS DIRECT DELIVERY SYSTEM2Cleared 510(K)
- K973541MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED2Cleared 510(K)
- K965091TEETHMATE F-12Cleared 510(K)
- K963921PULPDENT SEAL-RITE UDMA2Cleared 510(K)
- K961190GLY-ETCH2Cleared 510(K)
- K954867IONOSIT SEAL2Cleared 510(K)
- K954827SEALITE FL2Cleared 510(K)
- K954701AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING2Cleared 510(K)
- K952240TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION2Cleared 510(K)
- K951296DELTON F PIT & FISSURE SEALANT2Cleared 510(K)
- K945378PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT2Cleared 510(K)
- K935727P&FS PIT AND FISSURE SEALANT2Cleared 510(K)
- K932794PULPDENT SEAL-RITE LOW VISCOSITY2Cleared 510(K)
- K932078HELIOSEAL F2Cleared 510(K)
- K932002BARITONE C2, MODIFICATION2Cleared 510(K)
- K931868PRIMADRY PRODUCT LINE2Cleared 510(K)
- K931869ULTRASEAL XT PIT AND FISSURE SEALANT PRODUCT LINE2Cleared 510(K)
- K931857SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT2Cleared 510(K)
- K924824MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE2Cleared 510(K)
- K923895QUIKSEAL2Cleared 510(K)
- K924635ALPHA-DENT PIT AND FISSURE SEALANT2Cleared 510(K)
- K921599ULTRADENT PRODUCT DENTIN CONDITION & SEAL PROD LIN2Cleared 510(K)
- K921600ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE2Cleared 510(K)
- K913853FISSURE SEALER2Cleared 510(K)
- K915095ESTISEAL LC2Cleared 510(K)
- K914322BARITONE C2 & BARITONE L32Cleared 510(K)
- K914319PIT AND FISSURE SEALANT PRODUCTS2Cleared 510(K)
- K911287PULPDENT SEAL RITE2Cleared 510(K)
- K910813MET-ETCH2Cleared 510(K)
- K905582POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND2Cleared 510(K)
- K902742DEGUFILL (TM) WHIT-SEALANT2Cleared 510(K)
- K902022SEAL RITE(TM)2Cleared 510(K)
- K902023SEAL RITE PROCEDURE KIT(TM)2Cleared 510(K)
- K896341FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE2Cleared 510(K)
- K897027TEETHMATE-A2Cleared 510(K)
- K891140OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT2Cleared 510(K)
- K890494FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS2Cleared 510(K)
- K890464ZENITH 40% PHOSPHORIC ACID GEL2Cleared 510(K)
- K875091ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT2Cleared 510(K)
- K874944MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT2Cleared 510(K)
- K874557BISCO PORCELAIN REPAIR KIT2Cleared 510(K)
- K874556BISCO PIT AND FISSURE SEALANT2Cleared 510(K)
- K873069MODIFIED VISIO-SEAL2Cleared 510(K)
- K870579ALPHA-DENT PIT AND FISSURE SEALANT2Cleared 510(K)
- K862695FLUOR-ETCH GEL ETCHANT2Cleared 510(K)
- K862660PRISMA METAL OPAQUERS2Cleared 510(K)
- K862284SEALITE2Cleared 510(K)
- K861245ORTHOSOURCE ETCH SYSTEMS2Cleared 510(K)
- K854882PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT2Cleared 510(K)
- K854494CERAM-ETCH2Cleared 510(K)
- K845034FOREMOST LITE CURE PIT & FISSURE SEALANT2Cleared 510(K)
- K844308PIT AND FISSURE SEAANTS2Cleared 510(K)
- K844211CONCISE LIGHT CURED WHITE SEALANT2Cleared 510(K)
- K844057C-22 PIT & FISSURE SEALANT2Cleared 510(K)
- K843024COMMAND ULTRASEAL PIT & FISSURE SEALANT2Cleared 510(K)
- K843098APCO FISSURE SEALER & BONDING AGENT2Cleared 510(K)
- K842392DELTON * OPAQUE LIGHT CURING PIT2Cleared 510(K)
- K831380DELTON LIGHT CURING PIT & FISSURE2Cleared 510(K)
- K813015HELIOSEAL2Cleared 510(K)
- K813091FISSURE SEALER & BONDING AGENT2Cleared 510(K)
- K812549BEAUSEAL2Cleared 510(K)
- K811624VISIO-SEAL2Cleared 510(K)
- K810950VISIO-SEAL2Cleared 510(K)
- K802682CONTACT SEAL2Cleared 510(K)
- K802562PRISMA SEAL2Cleared 510(K)
- K801274S.S. WHITE-PENNWALT PRELUDE PIT SEALANT2Cleared 510(K)
- K800391PAINT-ON-RESTORATIVE W/FISSURE SEALER2Cleared 510(K)
- K790935DELTON* PIT AND FISSURE SEALENT2Cleared 510(K)
- K790788FISSURE SEALER AND BONDING AGENT2Cleared 510(K)
- K790596ENAMEL BOND SYSTEM2Cleared 510(K)
- K771402NUVA-COTE (MODIFICATION TO)2Cleared 510(K)
- K771327UVIOFIL2Cleared 510(K)
- K76041890752Cleared 510(K)
- K760405SEALANT, NEW FILLED2Cleared 510(K)
- 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
PRIMADRY PRODUCT LINE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K931868
- 510(k) Type
- Traditional
- Applicant
- ULTRADENT PRODUCTS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/22/1993
- Days to Decision
- 99 days
- Submission Type
- Statement