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
- K252165ZIRCONOMER P2Cleared 510(K)
- K250953EQUIA LC ONE2Cleared 510(K)
- K251775RODIN Cement2Cleared 510(K)
- K251470ResiCem EX2Cleared 510(K)
- K250156Choice 2 DC2Cleared 510(K)
- K250566EsCem RMGI2Cleared 510(K)
- K242366OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment2Cleared 510(K)
- K240714Insure® Universal; Insure® Universal Automix2Cleared 510(K)
- K241204TopCEM-Veneer Light Cure Veneer Cement2Cleared 510(K)
- K240888Calibra Abutment Resin Cement2Cleared 510(K)
- K233161BeautiLink SA2Cleared 510(K)
- K231552Dia-Cem2Cleared 510(K)
- K214076EsCem2Cleared 510(K)
- K222253GlasIonomer FX ULTRA2Cleared 510(K)
- K214118Riva Cem Automix2Cleared 510(K)
- K220640Bifix Hybrid Abutment Cement2Cleared 510(K)
- K213609NOVA RESIN dual cure, self adhesive resin cement2Cleared 510(K)
- K213201DeltaFil, DeltaFil Conditioner2Cleared 510(K)
- K210259Parkell Self-Adhesive Cement2Cleared 510(K)
- K210473Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)2Cleared 510(K)
- K211237UltraTemp Rez II2Cleared 510(K)
- K210504PANAVIA Veneer LC2Cleared 510(K)
- K200555Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)2Cleared 510(K)
- K200798G-CEM ONE2Cleared 510(K)
- K201937Ceramir Restore QuikCap2Cleared 510(K)
- K201790Dual Cure Resin Cement2Cleared 510(K)
- K201856Provicol QM Aesthetic2Cleared 510(K)
- K193260U-Cem Premium & MAZIC Cem2Cleared 510(K)
- K193484GC Fuji Triage EP2Cleared 510(K)
- K192007TheraBase, TheraBase Ca2Cleared 510(K)
- K192530Surefil one Self-adhesive Composite Hybrid2Cleared 510(K)
- K191527Visalys CemCore, Visalys Cem Core Try In Paste2Cleared 510(K)
- K192992Suglue 32Cleared 510(K)
- K183465Allcem, Allcem Core2Cleared 510(K)
- K191548Nexus Universal Self-Cure2Cleared 510(K)
- K182854GC FujiCEM 2 (Improved)2Cleared 510(K)
- K1911223M RelyX Pediatric Resin Modified Glass Ionomer Cement2Cleared 510(K)
- K183537PANAVIA SA Cement Universal2Cleared 510(K)
- K171449Metacem2Cleared 510(K)
- K180386Meron Plus QM2Cleared 510(K)
- K172382GC Fuji Direct2Cleared 510(K)
- K162960TotalC-Ram2Cleared 510(K)
- K160345Glass Ionomer Cement2Cleared 510(K)
- K1703303M Protemp Cement Temporary Dental Cement2Cleared 510(K)
- K160800DuoCem2Cleared 510(K)
- K161851Glass Ionomer Cement (Luting)2Cleared 510(K)
- K160443TempoCem Clear2Cleared 510(K)
- K160774IonoStar Plus2Cleared 510(K)
- K161256TheraCem2Cleared 510(K)
- K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer2Cleared 510(K)
- K142130ORAL BOND2Cleared 510(K)
- K153174Ketac Universal Aplicap2Cleared 510(K)
- K152652PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement2Cleared 510(K)
- K152691EDS Universal Cement2Cleared 510(K)
- K151526Zone, ZoneFree, Zone A12Cleared 510(K)
- K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer2Cleared 510(K)
- K151332Nexus Universal, Nexus Universal Chroma2Cleared 510(K)
- K150601Zeramic Adhesive Resin Cement2Cleared 510(K)
- K150727ESTECEM2Cleared 510(K)
- K142446Fixtemp Cement2Cleared 510(K)
- K143212Bifix Temp2Cleared 510(K)
- K142623PANAVIA SA Cement Plus Handmix2Cleared 510(K)
- K142625PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS)2Cleared 510(K)
- K141503DENALI 501CEMENT2Cleared 510(K)
- K140993IONOSTAR MOLAR2Cleared 510(K)
- K134021ESTEMP IMPLANT, ESTEMP CLEAR2Cleared 510(K)
- K132393CERCOM II CEMENT2Cleared 510(K)
- K132255ULTRACEM2Cleared 510(K)
- K130436MULTILINK HYBRID ABUTMENT CEMENT2Cleared 510(K)
- K130421MERON APPLICATION CAPSULES2Cleared 510(K)
- K122551PROVITEMP2Cleared 510(K)
- K122974TRYOUT-VPS HOLDING PASTE2Cleared 510(K)
- K122549DENTO TEMP2Cleared 510(K)
- K121804PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM2Cleared 510(K)
- K130223RMGI FILL2Cleared 510(K)
- K123824VITRO FIL LC2Cleared 510(K)
- K123595NEXUS RMGI2Cleared 510(K)
- K123826VITRO MOLAR2Cleared 510(K)
- K121621SOLOCEM2Cleared 510(K)
- K123273HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)2Cleared 510(K)
- K123265RMGI LOW VISCOSITY2Cleared 510(K)
- K120283DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT2Cleared 510(K)
- K120243GAM-2002Cleared 510(K)
- K120159BEAUTICEM SA2Cleared 510(K)
- K120432TELIO CS CEM IMPLANT2Cleared 510(K)
- K120379PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S2Cleared 510(K)
- K120378PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S2Cleared 510(K)
- K112307RESIGLASS PASTE2Cleared 510(K)
- K112574PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT2Cleared 510(K)
- K113040CERAMIR CROWN & BRIDGE2Cleared 510(K)
- K111855HY-BOND RESIGLASS2Cleared 510(K)
- K111836PERMASHADE VENEER CEMENT2Cleared 510(K)
- K111685IP TEMP CEMENT2Cleared 510(K)
- K111017CLEARTEMP2Cleared 510(K)
- K110508SUGLUE-102Cleared 510(K)
- K111185RELYX LUTING PLUS AUTOMIX2Cleared 510(K)
- K103585BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP2Cleared 510(K)
- K102612VOCO IONOFIL MOLAR AC QUICK2Cleared 510(K)
- K101504TI-CORE FLOW2Cleared 510(K)
- K101787DUOLINK II2Cleared 510(K)
- K101869PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)2Cleared 510(K)
- K101420GC FUJI TEMP2Cleared 510(K)
- K101493ADVANCED GLASS IONOMER (K-130) RESTORATIVE2Cleared 510(K)
- K100247DETAX IMPLANTLINK SEMI2Cleared 510(K)
- K100908UNICEM HM2Cleared 510(K)
- K101044RETRIEVE IMPLANT CEMENT2Cleared 510(K)
- K100756MALTA2Cleared 510(K)
- K094007UNICEM2Cleared 510(K)
- K100510CERAMIR CROWN & BRIDGE2Cleared 510(K)
- K100290ESTEMP NE2Cleared 510(K)
- K093338SELF ADHESIVE COMPOSITE LUTING CEMENT2Cleared 510(K)
- K091735DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT2Cleared 510(K)
- K090817IONOLUX2Cleared 510(K)
- K091106EQUIA2Cleared 510(K)
- K091019SPEEDCEM2Cleared 510(K)
- K083766PHOGLASS CEM2Cleared 510(K)
- K083516PERIOGENIX2Cleared 510(K)
- K083438BIFIX SE2Cleared 510(K)
- K083304TEMPOSIL 22Cleared 510(K)
- K083398CERCOM CEMENT2Cleared 510(K)
- K082115PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT2Cleared 510(K)
- K082449BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-450122Cleared 510(K)
- K081913METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER2Cleared 510(K)
- K081702CARBOXYLATE CEM, PHOSPHATE CEM2Cleared 510(K)
- K081887LUTE-IT II VENEER CEMENT, MODEL NO62Cleared 510(K)
- K081405XERACEM2Cleared 510(K)
- K081583CLEARFIL SA CEMENT2Cleared 510(K)
- K080517RESICEM2Cleared 510(K)
- K080768ULTRATEMP FIRM, FAST AND REGULAR SET2Cleared 510(K)
- K073698SECURE2Cleared 510(K)
- K073283GC GAM-1002Cleared 510(K)
- K073173SELF-ADHESIVE RESIN CEMENT2Cleared 510(K)
- K073395GILB-2, GLASS IONOMER PROTECTIVE COATING2Cleared 510(K)
- K073101AURAVENEER CEMENT2Cleared 510(K)
- K073043SET PP2Cleared 510(K)
- K072604DUO TEMP2Cleared 510(K)
- K071484PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 60402Cleared 510(K)
- K070840GVC-1002Cleared 510(K)
- K070319GC FUJI IX GP EXTRA2Cleared 510(K)
- K063554MERON PLUS2Cleared 510(K)
- K062355ENA CEM2Cleared 510(K)
- K062065RIVA LUTING PLUS2Cleared 510(K)
- K062064RIVA BOND LC2Cleared 510(K)
- K062292UNICEM2Cleared 510(K)
- K062519NEXUS 32Cleared 510(K)
- K062410CLEARFIL ESTHETIC CEMENT & DC BOND2Cleared 510(K)
- K061781MULTILINK SPRINT2Cleared 510(K)
- K061535GC XLC-100 CAPSULE2Cleared 510(K)
- K060701BISCEM TRANSLUCENT, BISCEM OPAQUE2Cleared 510(K)
- K060698CEMENT-IT ALL PURPOSE, MODEL N972Cleared 510(K)
- K060894BIFIX QM2Cleared 510(K)
- K060334GI DENTSTAT2Cleared 510(K)
- K053565TEMPBOND CLEAR WITH TRICLOSAN2Cleared 510(K)
- K053040PARACEM UNIVERSAL DC2Cleared 510(K)
- K052235LCR2Cleared 510(K)
- K051952EUGENONE2Cleared 510(K)
- K051866PREMIER TEMPORARY CEMENT2Cleared 510(K)
- K051427GC FUJI FIL LC2Cleared 510(K)
- K051008SET2Cleared 510(K)
- K050870RIVA LIGHT CURE2Cleared 510(K)
- K050658RESO-PAC PERIODONTAL DRESSING2Cleared 510(K)
- K050426TEMPOSIL, MODEL 67202Cleared 510(K)
- K042846SYSTEMP.LINK2Cleared 510(K)
- K042847SYSTEMP.CEM2Cleared 510(K)
- K042452RIVA SILVER2Cleared 510(K)
- K042669IONOFIL PLUS AC2Cleared 510(K)
- K041272DYRACT CEM PLUS CEMENT2Cleared 510(K)
- K042215RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT2Cleared 510(K)
- K040343TEMP F2Cleared 510(K)
- K041474MAXCEM2Cleared 510(K)
- K040906CALIBRA CEMENT2Cleared 510(K)
- K040895INTEGRITY TEMPORARY CEMENT2Cleared 510(K)
- K040393RIVA LUTING2Cleared 510(K)
- K040236PULPDENT VLC RESIN CEMENT2Cleared 510(K)
- K033309PREMIER IMPLANT CEMENT, MODEL 30014502Cleared 510(K)
- K031494DOC'S BEST WHITE COPPER CEMENT2Cleared 510(K)
- K032455PANAVIA F 2.02Cleared 510(K)
- K032470MULTILINK2Cleared 510(K)
- K032597BISCEM GI2Cleared 510(K)
- K033068IONOFIL COLOR AC2Cleared 510(K)
- K032175DESENS-IONOMER2Cleared 510(K)
- K031752COLTOSOL F2Cleared 510(K)
- K031467GLASIONOMER FX-II2Cleared 510(K)
- K031212TEMPORARY RESIN CEMENT2Cleared 510(K)
- K030727POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT2Cleared 510(K)
- K030516RIVA-SELF CURE2Cleared 510(K)
- K030168AGC CEM2Cleared 510(K)
- K024287FIXOBRIDGE 3-CEMENT2Cleared 510(K)
- K023888CIMOFLUOR2Cleared 510(K)
- K023981AHL GENERIC GLASS IONOMER LUTING CEMENT2Cleared 510(K)
- K023649VITIQUE SYSTEM2Cleared 510(K)
- K023727TEMPORARY CEMENT-DC0100022Cleared 510(K)
- K022150TRIONOMER2Cleared 510(K)
- K022476RELYX RMGIP2Cleared 510(K)
- K021038GC ELITE CEMENT 1002Cleared 510(K)
- K020481PULPDENT POST CEMENT2Cleared 510(K)
- K020376AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE2Cleared 510(K)
- K020256UNICEM2Cleared 510(K)
- K020117GC FUJI LINING LC PASTE PAK2Cleared 510(K)
- K013555SCI-PHARM POST SECURE2Cleared 510(K)
- K013609NEXUS 2 CLEAR2Cleared 510(K)
- K013446GLUSITE, MODEL GLU0022Cleared 510(K)
- K013198FUJI VII CAPSULE2Cleared 510(K)
- K013008NEXUS 2 MODIFIED2Cleared 510(K)
- K012735CLEARFIL DC CEMENT2Cleared 510(K)
- K012441PANAVIA F2Cleared 510(K)
- K012438MODIFICATION TO PANAVIA 212Cleared 510(K)
- K011854TOKUYAMA M-BOND2Cleared 510(K)
- K012316PERMACEM / PERMACEM DUAL2Cleared 510(K)
- K011685BISTITE II DC2Cleared 510(K)
- K010541PREVISION CHEM2Cleared 510(K)
- K011520RESTORE-X2Cleared 510(K)
- K011200GILB, MODEL 80102Cleared 510(K)
- K011431RESIN CEM2Cleared 510(K)
- K011159ONE-STEP PLUS2Cleared 510(K)
- K011064CLASSIC CEM2Cleared 510(K)
- K010240POLYCARBOXYLATE (PCA) CEMENT2Cleared 510(K)
- K003407SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER)2Cleared 510(K)
- K003921DYRACT CEM LCI COMPOMER2Cleared 510(K)
- K003427ZINC PHOSPHATE CEMENT2Cleared 510(K)
- K003791CAVEX TEMPORARY CEMENT2Cleared 510(K)
- K003658TEMP-BOND NE 22Cleared 510(K)
- K002843SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 700102Cleared 510(K)
- K0024523M RELY X VENEER CEMENT TRY-IN PASTER2Cleared 510(K)
- K002793KETAC CEM U2Cleared 510(K)
- K002461HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT2Cleared 510(K)
- K002322MODIFICATION TO PANAVIA F2Cleared 510(K)
- K001823LINKMAX2Cleared 510(K)
- K001730GC FUJICEM2Cleared 510(K)
- K000173CEMENT IT! UNIVERSAL C&B2Cleared 510(K)
- K994261ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT2Cleared 510(K)
- K993556LIQUIBAND DENTAL2Cleared 510(K)
- K993710MODIFICATION OF PARAPOST CEMENT2Cleared 510(K)
- K993324CARBOCEM ZINC POLYCARBOXYLATE CEMENT2Cleared 510(K)
- K991974FUTURA GLASS IONOMER SILVER REINFORCED2Cleared 510(K)
- K992160NEXUS 22Cleared 510(K)
- K991711BISTITE II SC2Cleared 510(K)
- K991172IONOSIT BOND2Cleared 510(K)
- K990381TOTALBOND2Cleared 510(K)
- K990155HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 700102Cleared 510(K)
- K984505MIRACLE MIX POWDER/LIQUID2Cleared 510(K)
- K984340STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/2202812Cleared 510(K)
- K984248PROCEM2Cleared 510(K)
- K983752ALUMINA-ZINC OXIDE POWDERS F AND R2Cleared 510(K)
- K983361PANAVIA F2Cleared 510(K)
- K982773QUICKSET LIQUID AND POWDER2Cleared 510(K)
- K983018ZINC PHOSPHATE CEMENT2Cleared 510(K)
- K982913ZINFOS ZINC PHOSPHATE CEMENT2Cleared 510(K)
- K982895STERNOMEGA COMPOMER CEMENT2Cleared 510(K)
- K982590TEMPBOND CLEAR-22Cleared 510(K)
- K982779MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 12Cleared 510(K)
- K982400STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT2Cleared 510(K)
- K982665JUMBO SILVER-REINFORCED GLASS IONOMER2Cleared 510(K)
- K982461GLASIONOMER CEMENT CX PLUS2Cleared 510(K)
- K980990POLYCARBOXYLATE CEMENT2Cleared 510(K)
- K981618LIQUID A2Cleared 510(K)
- K973636MCS-MEDICATED CANAL SEALER2Cleared 510(K)
- K981965FLOWABLE COMPOSITE2Cleared 510(K)
- K981335ARISTON PHC LINER2Cleared 510(K)
- K973201PROVI CEMENT2Cleared 510(K)
- K981370MIRACLE MIX CAPSULE2Cleared 510(K)
- K980922PROTEC CEM.2Cleared 510(K)
- K980568JUMBO GLASS IONOMER CEMENT2Cleared 510(K)
- K980695FUJI I2Cleared 510(K)
- K980159OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A012Cleared 510(K)
- K974097PERIACRYL2Cleared 510(K)
- K980682FUJI II2Cleared 510(K)
- K980232CLEARFIL DC CEMENT2Cleared 510(K)
- K974458COMPOLUTE APLICAP2Cleared 510(K)
- K972935SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL2Cleared 510(K)
- K974140ADHESIVE HYBRID IONOMER CEMENT2Cleared 510(K)
- K974014PULPDENT DENTASTIC UNO2Cleared 510(K)
- K9739613M DENT SYSTEM II PLUS2Cleared 510(K)
- K973370AQUAPLAST PALATAL STENT2Cleared 510(K)
- K973397SYNTAC SPRINT2Cleared 510(K)
- K973262KETAC-FIL APLICAP PLUS2Cleared 510(K)
- K972965STERI-OSS UNTIL IMPLANT CEMENT2Cleared 510(K)
- K972844TEMP BOND CLEAR2Cleared 510(K)
- K972445PULPDENT OX-OUT2Cleared 510(K)
- K972485CIMPAT N2Cleared 510(K)
- K971642DENTALIS KEZ ENDODONITC SEALER2Cleared 510(K)
- K971927HI DENSE TC2Cleared 510(K)
- K970775TEMPO CEM (MULTIPLE)2Cleared 510(K)
- K970774TEMPOCEM NE (MULTIPLE)2Cleared 510(K)
- K964808SPETEMP2Cleared 510(K)
- K964773DENTEMP ONE STEP2Cleared 510(K)
- K964809SPETEMP EF2Cleared 510(K)
- K963737HYCEM APLICAP2Cleared 510(K)
- K962733CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920)2Cleared 510(K)
- K962747PULPDENT ENDODONTIC POST CEMENT KIT2Cleared 510(K)
- K963078STERI-OSS TEMPORARY IMPLANT CEMENT2Cleared 510(K)
- K962383PULPDENT RESILUTE II2Cleared 510(K)
- K9620653M VITREBOND LIGHT CURE GLASS IONOMER/BASE2Cleared 510(K)
- K961448FUJI IX GP2Cleared 510(K)
- K961910VIVAGLASS FIL2Cleared 510(K)
- K962297VIVAGLASS CEM2Cleared 510(K)
- K961584FUJI II LC (IMPROVED)2Cleared 510(K)
- K960954KETAC-MOLAR APLICAP2Cleared 510(K)
- K960910INDERMIL DENTAL2Cleared 510(K)
- K960464C & B METABOND (MODIFICATION)2Cleared 510(K)
- K955089ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT2Cleared 510(K)
- K955068OPTIBOND 2A PRECOAT2Cleared 510(K)
- K955017PULPDENT RESILUTE2Cleared 510(K)
- K954876AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA2Cleared 510(K)
- K954762NEXUS2Cleared 510(K)
- K954643TRY-IN GEL2Cleared 510(K)
- K954177ALPHA-BOND DENTIN BONDING SYSTEM2Cleared 510(K)
- K953301DENTASTIC ONE-STEP2Cleared 510(K)
- K953272PULPDENT DENTASTIC II2Cleared 510(K)
- K952960PULPDENT POST CEMENT2Cleared 510(K)
- K9521213M RESIN CEMENT2Cleared 510(K)
- K951270PULPDENT GLASS IONOMER CEMENTS2Cleared 510(K)
- K951555FUJI IX2Cleared 510(K)
- K945451HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE2Cleared 510(K)
- K950428VIVAGLASS BASE2Cleared 510(K)
- K950060PROVILINK2Cleared 510(K)
- K945366PARAPOST CEMENT2Cleared 510(K)
- K946137PULPDENT PERIODONTAL DRESSINGS2Cleared 510(K)
- K946100FUJI DUET2Cleared 510(K)
- K945244PULP CANAL SEALER EWT2Cleared 510(K)
- K944480SEALAPEX2Cleared 510(K)
- K942808TYPE I GLASS IONOMER CEMENT2Cleared 510(K)
- K926376MION 5252Cleared 510(K)
- K940914NEW LUTING CEMENT MATERIAL (NLC)2Cleared 510(K)
- K942665ORTHOCENT: LIQUID AND POWDER2Cleared 510(K)
- K942596ALPHA-LOCK OR PRO-LOCK FLUORIDE RELEASING GLASS IONOMER BAND CEMENT2Cleared 510(K)
- K941065DEOX, OXYGEN BARRIER VISCOUS SOLUTION2Cleared 510(K)
- K935436ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED2Cleared 510(K)
- K940122HY BOND, GLASIONOMER CX2Cleared 510(K)
- K940546GRANITEC IONOMER RESIN CEMENT2Cleared 510(K)
- K940459MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF)2Cleared 510(K)
- K933612JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT)2Cleared 510(K)
- K933030PANAVIA 212Cleared 510(K)
- K940030BISCO COMPOSITE2Cleared 510(K)
- K934073JEDENTAL GLASS IONOMER CEMENT AND LINER2Cleared 510(K)
- K922250FLEXI-FLOW CEMENT WITH TITANIUM2Cleared 510(K)
- K922249FLEXI-FLOW CEMENT NATURAL2Cleared 510(K)
- K934405PRECEDENT2Cleared 510(K)
- K935521GC ELITE CEMENT2Cleared 510(K)
- K933199CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL2Cleared 510(K)
- K9331393M VITREMER LUTING CEMENT2Cleared 510(K)
- K934184FASTFIL2Cleared 510(K)
- K933554JEDENTAL ZINC CEMENT IMPROVED2Cleared 510(K)
- K933543ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT)2Cleared 510(K)
- K933459RESIMENT WITH FLUORIDE2Cleared 510(K)
- K931229VARIGLASS VLC GLASS IONOMER2Cleared 510(K)
- K925207GLASS IONOMER CEMENT2Cleared 510(K)
- K924132E.Z. TEMEP, TEMPORARY FILLING MATERIAL2Cleared 510(K)
- K925027PHOTAC-FIL APLICAP2Cleared 510(K)
- K930116LCL 82Cleared 510(K)
- K931084TEMPIT2Cleared 510(K)
- K923473MULTIPURPOSE RESIN CEMENT2Cleared 510(K)
- K930455CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER2Cleared 510(K)
- K926492ARGION DENTAL CEMENT2Cleared 510(K)
- K926458BIFIX DENTAL CEMENT2Cleared 510(K)
- K925713VITA CEREC DUO CEMENT2Cleared 510(K)
- K9250323M VITREMER TRI-CURE GLASS IONOMER SYSTEM2Cleared 510(K)
- K921173TYPE 1 DENTAL CEMENT2Cleared 510(K)
- K923328VENEER CEMENT2Cleared 510(K)
- K922853AQUA IONOFIL2Cleared 510(K)
- K922638TEMPIT-E2Cleared 510(K)
- K922854AQUA MERON2Cleared 510(K)
- K915666AMALCODEN2Cleared 510(K)
- K914318GLASS IONOMER CEMENT2Cleared 510(K)
- K915619IONOFIL/LONOFIL MOLAR2Cleared 510(K)
- K915618PROVICOL2Cleared 510(K)
- K915467CIMPAT S DENTAL CEMENT2Cleared 510(K)
- K914612MERON DENTAL CEMENT2Cleared 510(K)
- K915005PHOTAC-BOND APLICAP, MODIFICATION2Cleared 510(K)
- K911061ESPE KETAC-ENDO APLICAP2Cleared 510(K)
- K914324CAVITY VARNISH PRODUCT2Cleared 510(K)
- K913519SUMO GLASS IONOMER CEMENT2Cleared 510(K)
- K913884FUJI II LC2Cleared 510(K)
- K914073F21(R) DENTAL CEMENT2Cleared 510(K)
- K913836VLC GLASS IONOMER2Cleared 510(K)
- K913572AUTOPACK NON-EUGENOL PERIODONTAL DRESSING2Cleared 510(K)
- K912497IONOBOND2Cleared 510(K)
- K9118423M LUTING CEMENT, PASTE A AND B2Cleared 510(K)
- K910719SILICOATER MD2Cleared 510(K)
- K910424TEETHMATE-F2Cleared 510(K)
- K904034TEMPORARY DENTAL CEMENT2Cleared 510(K)
- K904024CEMPER2Cleared 510(K)
- K901524CHEMFIL II CAPS2Cleared 510(K)
- K902817SURGI PAK NE AND COCOMENT EUGENAL FREE PASTE SYST2Cleared 510(K)
- K902392COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL2Cleared 510(K)
- K902078ADD'L INDICATION FOR OCTYLDENT 2-OCTYL CRANOACRY.2Cleared 510(K)
- K902894POST CEMENT (DENTAL COMPOSITE)2Cleared 510(K)
- K902052AHYDRON DENTAL CLEANING AGENT2Cleared 510(K)
- K902635MODIFIED GRANITEC P2 & G2 DENTAL CEMENTS2Cleared 510(K)
- K901082CYANODONT DENTAL CEMENT2Cleared 510(K)
- K896883GC CERVICAL CEMENT2Cleared 510(K)
- K9020413M LUTING CEMENT - PASTE A AND PASTE B2Cleared 510(K)
- K896340BIOMER(R) F COMPOSITE LUTING CEMENT2Cleared 510(K)
- K900342UNITY DENTAL CEMENT2Cleared 510(K)
- K895386GLASION2Cleared 510(K)
- K900303CONNECT2Cleared 510(K)
- K895487TEMPORARY DENTAL CEMENT2Cleared 510(K)
- K897188KETAC-CEM MAXICAP2Cleared 510(K)
- K895988POTASSIUM NITRATE-ZINC OXIDE EUGENOL TEMP. DENTAL2Cleared 510(K)
- K896649GRANITEC Z2, ZINC PHOSPHATE CEMENT2Cleared 510(K)
- K894953GRANITEC P2 AND GRANITEC G2 DENTAL CEMENTS2Cleared 510(K)
- K896249BANDTITE GLASS IONOMER CEMENT2Cleared 510(K)
- K894477INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM2Cleared 510(K)
- K895798SILCOT COPAL CAVITY VARNISH2Cleared 510(K)
- K892453KULZER GLAS-IONOMER CEMENT2Cleared 510(K)
- K894219TEMP BOND NE2Cleared 510(K)
- K891607DENTANURSE2Cleared 510(K)
- K884652OCTYLDENT2Cleared 510(K)
- K890623FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENT2Cleared 510(K)
- K890608FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENT2Cleared 510(K)
- K885007CIMPAT S TEMPORARY DENTAL CEMENT2Cleared 510(K)
- K882417POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT2Cleared 510(K)
- K884475CHELON-FIL2Cleared 510(K)
- K884081INTERIM, TEMPORARY CEMENT2Cleared 510(K)
- K883770RESUBMITTED EMA DENTIN CEMENT2Cleared 510(K)
- K883698ZINC OXIDE EUGENOL TEMPORARY CEMENT2Cleared 510(K)
- K881422COE PAK AUTO MIX, REGULAR OR HARD SET2Cleared 510(K)
- K881918LIGHT-CURED ZIONOMER CEMENT2Cleared 510(K)
- K881914COVER UP2Cleared 510(K)
- K881890PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT2Cleared 510(K)
- K881661IONOSCEM OR IONOSCELL GLASS IONOMER DENTAL CEMENT2Cleared 510(K)
- K880251KERR XR IONOMER2Cleared 510(K)
- K880250KERR XR BOND2Cleared 510(K)
- K880848FUJI CAP II CAPSULE & APPLIER2Cleared 510(K)
- K880685PORCELITE DUAL CURE CEMENT2Cleared 510(K)
- K874788KETAC-BOND APLICAP2Cleared 510(K)
- K874458PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER2Cleared 510(K)
- K872984KETAC-CONDITIONER2Cleared 510(K)
- K874945CEMENT LINER2Cleared 510(K)
- K874500GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM.2Cleared 510(K)
- K873356INSURE PORCELAIN VENEER BONDING SYSTEM2Cleared 510(K)
- K871562IONOCAL2Cleared 510(K)
- K864720LIGHT-CURED PERIODONTAL DRESSING2Cleared 510(K)
- K870211BONDEX* GLASS IONOMER CEMENT2Cleared 510(K)
- K870334BOSTON POST CEMENT2Cleared 510(K)
- K870209NEXADENT (DENTAL CEMENT)2Cleared 510(K)
- K864898FOREMOST DENTIN ADHESIVE2Cleared 510(K)
- K864725MODI. DICOR CASTABLE CERAMIC/ALL PORCELAIN BRIDGES2Cleared 510(K)
- K8642703M GLASS IONOMER LINER2Cleared 510(K)
- K863141KULZER GLASS IONOMER LINER2Cleared 510(K)
- K862280SHOFU LINING CEMENT2Cleared 510(K)
- K861685SUPERLON (UNILON) CARBOXYLATE CEMENT2Cleared 510(K)
- K861005GLASIONOMER BASE CEMENT2Cleared 510(K)
- K855211PANAVIA EX, A DENTAL ADHESIVE2Cleared 510(K)
- K853090CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO2Cleared 510(K)
- K853091CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE2Cleared 510(K)
- K853447POLYCARB WATER SET2Cleared 510(K)
- K852196ZIONOMER CEMENT2Cleared 510(K)
- K85146876 EMA LINING CEMENT2Cleared 510(K)
- K850913GLAS IONOMER CEMENT2Cleared 510(K)
- K844846ESPE KETAC-CEM RADIOPAQUE2Cleared 510(K)
- K843566KETAC-SILVER2Cleared 510(K)
- K842995EMA LIV CENERA DENTAL CEMENT2Cleared 510(K)
- K842994EMA FREEGENOL DENTAL CEMENT2Cleared 510(K)
- K840407KERR RESIN BONDED BRIDGE CEMENT2Cleared 510(K)
- K841195GLAS IONOMER CEMENT2Cleared 510(K)
- K841196HY-BOND ZINC OXIDE EUGENOL TEMP.2Cleared 510(K)
- K830113SEPTOPACK2Cleared 510(K)
- K830440DENTA PLAST2Cleared 510(K)
- K830117ENDOMET2Cleared 510(K)
- K830107SELFAST2Cleared 510(K)
- K823935MICRO JOIN, CROWN & BRIDGE ADHESIVE2Cleared 510(K)
- K823795EVERBOND GLASS IONOMER CEMENT2Cleared 510(K)
- K821824TEM-STIK2Cleared 510(K)
- K821326CUTTER BOND POLYCARBOXYLATE CEMENT2Cleared 510(K)
- K813532CUTTERBOND ZINC PHOSPHATE CEMENT2Cleared 510(K)
- K813380CAVIDENTIN2Cleared 510(K)
- K812858CHEMFIL2Cleared 510(K)
- K812532TEMP-FILL2Cleared 510(K)
- K812568CAVITRON2Cleared 510(K)
- K812115KETAC-CHEM2Cleared 510(K)
- K811521FUJI IONOMER TYPE I & II2Cleared 510(K)
- K810764HY-BOND POLYCARBOXYLATE CEMENT2Cleared 510(K)
- K810765HY-BOND ZINC PHOSPHATE CEMENT2Cleared 510(K)
- K810545PCA PERIOCARE PERIODONTAL DRESSING2Cleared 510(K)
- K810026DENTAL ENDODONTIC CEMENT2Cleared 510(K)
- K802662POLYCARBONATE TEMPORARY CEMENT2Cleared 510(K)
- K802819KETAC-CEM IN REF. TO K8020482Cleared 510(K)
- K801227SILICAP2Cleared 510(K)
- K801236REIGNING EPOXY RESIN CEMENT2Cleared 510(K)
- K801229BONDALCAP (CARBOXYLATE)2Cleared 510(K)
- K801228BONDALCAP (SILICO-PHOSPHATE)2Cleared 510(K)
- K791160DENTALEEN2Cleared 510(K)
- K800060PROVIT2Cleared 510(K)
- K790593DENTAL CEMENT, ZINC PHOSPHATE2Cleared 510(K)
- K790586CHEMBOND2Cleared 510(K)
- K790832KETAC APPLIC-CAPSULES2Cleared 510(K)
- K790127CEMENT, CERAMCO2Cleared 510(K)
- K781281CEMENT, DENTAL/CAVITY LINER2Cleared 510(K)
- K780301CAULK TYLOK2Cleared 510(K)
- K771114NEUTROCIM2Cleared 510(K)
- K771481TONGUE BLADE HOLDER2Cleared 510(K)
- K771451SCUTABOND2Cleared 510(K)
- K770923ESPETEMP (TEMP. CEMENT)2Cleared 510(K)
- K770067CYANOBOND2Cleared 510(K)
- K761355SELFAST2Cleared 510(K)
- K761354CIMPAT (PINK AND WHITE)2Cleared 510(K)
- K760978ZINC CEMENT2Cleared 510(K)
- K760239CEMENT, ULTRA-BOND2Cleared 510(K)
- 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
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- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
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- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
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- UnknownReview Panel
GlasIonomer FX ULTRA
- Page Type
- Cleared 510(K)
- 510(k) Number
- K222253
- 510(k) Type
- Traditional
- Applicant
- Shofu Dental Corporation
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/22/2022
- Days to Decision
- 57 days
- Submission Type
- Statement