Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- MiscellaneousMiscellaneous
- LTGPaste, Injectable For Vocal Cord Augmentation3Product Code
- LWMDevice, Electrical Dental AnesthesiaUProduct Code
- MCLKit, Test, In Vitro Periodontal3Product Code
- MQCMouthguard, PrescriptionUProduct Code
- K240463Slow Wave DS8 (SWDS802)UCleared 510(K)
- K231793RODIN 3D Resin SPLINT, Hard/FlexUCleared 510(K)
- K232087Dental LT Comfort ResinUCleared 510(K)
- K230548Myoaligner ApplianceUCleared 510(K)
- K230592LuxCreo Dental Night Guard ResinUCleared 510(K)
- K222845Clench Relief Mouth Piece PRO RX, Clench Relief Mouth PieceUCleared 510(K)
- K230495Serena Sleep Night GuardUCleared 510(K)
- K232448FREEPRINT® splintmasterUCleared 510(K)
- K230237Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)UCleared 510(K)
- K222604dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version SUCleared 510(K)
- K223798Glidewell TuffSplint™ Appliance ResinUCleared 510(K)
- K222061Dental LT Clear V2 ResinUCleared 510(K)
- K221022NextDent Ortho FlexUCleared 510(K)
- K220894SmileGuardUCleared 510(K)
- K212017Thermeo SystemUCleared 510(K)
- K214102Glidewell Appliance Resin, Hard/SoftUCleared 510(K)
- K212767SleepRight Select-Comfort Dental GuardUCleared 510(K)
- K212448NightGuard FlexUCleared 510(K)
- K211415GR Splint Resin SystemUCleared 510(K)
- K210940LuxaPrint Ortho PlusUCleared 510(K)
- K210011JS Dental Lab Mouth GuardUCleared 510(K)
- K203596Panthera Occlusal ApplianceUCleared 510(K)
- K203000KeyPrint KeySplint HardUCleared 510(K)
- K201173E-GuardUCleared 510(K)
- K202465Night GuardUCleared 510(K)
- K201091V-Print splintUCleared 510(K)
- K200125Thermoforming Sheet MaterialsUCleared 510(K)
- K191836Ceramill A-SplintUCleared 510(K)
- K183598KeyPrint KeySplint SoftUCleared 510(K)
- K182820The PODUCleared 510(K)
- K190107VeriSplintUCleared 510(K)
- K181361Brux Night GuardUCleared 510(K)
- K170985Urbanek DeviceUCleared 510(K)
- K161884Ortho SystemUCleared 510(K)
- K151933BRX PRO Bruxism GuardUCleared 510(K)
- K143655SICAT OPTIMOTIONUCleared 510(K)
- K143623Narval BruxUCleared 510(K)
- K134015M-PM-DISCUCleared 510(K)
- K123161SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITEUCleared 510(K)
- K121365THERMOFORMED MOUTHGUARDSUCleared 510(K)
- K112868DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAXUCleared 510(K)
- K102909SOMNOBRUX SPLINTSUCleared 510(K)
- K111066MIGRA TAB, QUICKSPLINT MIGRAINEUCleared 510(K)
- K111828CLEARSPLINT ESUCleared 510(K)
- K110468FREEWAY COMFORT BITE GUARDUCleared 510(K)
- K091880CLAYTON INTRA-AURAL DEVICE (CID)UCleared 510(K)
- K090472GRIND GUARDUCleared 510(K)
- K082723GRINDGUARDUCleared 510(K)
- K072522THERMOFORM SHEET MATERIALS AND ACCESSORIESUCleared 510(K)
- K071404SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCEUCleared 510(K)
- K061122NIGHT GUARDUCleared 510(K)
- K063483DEN TEK NIGHTGUARDUCleared 510(K)
- K062828MOUTHGUARD AND ALIGNER MATERIALSUCleared 510(K)
- K053580DOCTOR'S NIGHTGUARDUCleared 510(K)
- K040315MYOHEALTH CLENCHING INHIBITORUCleared 510(K)
- K022809EZ SPLINT & EZ SPLINT PMUCleared 510(K)
- K030832PRIMOSPLINT SYSTEMUCleared 510(K)
- K024261DENTAL PROTECTORUCleared 510(K)
- K022627DSG RELAXER SPLINTUCleared 510(K)
- K014079DR. HAYS BITE GUARDUCleared 510(K)
- K980953ACCU-BITE HOME KIT DISCLUDERUCleared 510(K)
- K981546NTI CLENCHING SUPPRESSION SYSTEMUCleared 510(K)
- K955701NIGHTGUARD DIAGNOSTIC APPLIANCEUCleared 510(K)
- MVLCord, RetractionUProduct Code
- QMJPowered Radiofrequency Toothbrush2Product Code
- QNONeuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea2Product Code
- KJJCleanser, Root CanalUProduct Code
- LFDSaliva, ArtificialUProduct Code
- LMWSolution, Removal, Carries3Product Code
- LPGMaterial, Dressing, Surgical, Polylactic Acid3Product Code
- LQYLocator, Root ApexUProduct Code
- NSJRestoration, Noble MetalNProduct Code
- NSKDentures, PartialNProduct Code
- NSLDentures, FullNProduct Code
- NSMRestoration, ResinNProduct Code
- NSNRestoration, Resin, Crown And BridgeNProduct Code
- NSORestoration, Porcelain-Fused-To-MetalNProduct Code
- NSPRestoration, PorcelainNProduct Code
- NSQRestoration, Base MetalNProduct Code
- NSRProsthesis, OrthodonticNProduct Code
- NXJDenture, Cosmetic OnlyNProduct Code
- OBRMouthguard, Over-The-CounterUProduct Code
- OCOMouthguard, Migraine/Tension HeadacheUProduct Code
- OLROral Wound DressingUProduct Code
- OLSOral Wound Dressing W/Drug And/Or BiologicUProduct Code
- PKJCrown And Bridge Material, Resin BasedNProduct Code
- QUAIntraoral Cooling Device2Product Code
- SBCDental Image Analyzer2Product Code
- Submissions with No Product CodeMiscellaneous
- 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
- 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
Ortho System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K161884
- 510(k) Type
- Traditional
- Applicant
- 3Shape A/S
- Country
- Denmark
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/19/2017
- Days to Decision
- 282 days
- Submission Type
- Statement