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
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- DYJRetainer, Screw Expansion, Orthodontic1Product Code
- DYOBand, Material, Orthodontic1Product Code
- DYTMaintainer, Space Preformed, Orthodontic1Product Code
- DYWBracket, Plastic, Orthodontic2Product Code
- DZBHeadgear, Extraoral, Orthodontic2Product Code
- DZCWire, Orthodontic1Product Code
- DZDTube, Orthodontic1Product Code
- ECIBand, Elastic, Orthodontic1Product Code
- ECMBand, Preformed, Orthodontic1Product Code
- ECNClamp, Wire, Orthodontic1Product Code
- ECOSpring, Orthodontic1Product Code
- EJFBracket, Metal, Orthodontic1Product Code
- KKORing, Teething, Fluid-Filled2Product Code
- KMYPositioner, Tooth, Preformed1Product Code
- LQZDevice, Jaw Repositioning2Product Code
- LRKDevice, Anti-Snoring2Product Code
- LTFStimulator, Salivary System2Product Code
- MEFRing, Teething, Non-Fluid Filled1Product Code
- NJMBracket, Ceramic, Orthodontic2Product Code
- NLCBracket, Plastic, Orthodontic, Reprocessed2Product Code
- NQSBracket, Metal, Orthodontic, Reprocessed1Product Code
- NTORinse, Oral, Antibacterial (By Physical Means)2Product Code
- NXCAligner, Sequential2Product Code
- PLCSleep Appliances With Patient Monitoring2Product Code
- OHPExpiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea2Product Code
- ORYPrelude Tongue Suspension System2Product Code
- OYHOrthodontic Vibratory Accessory2Product Code
- PLHOrthodontic Led Accessory2Product Code
- PNNOrthodontic Software2Product Code
- K241153Progressive Orthodontics App2Cleared 510(K)
- K233625RAYDENT SW2Cleared 510(K)
- K232564Align Studio2Cleared 510(K)
- K233616Clevaligner Software (V1.0.0)2Cleared 510(K)
- K232549NemoCast2Cleared 510(K)
- K232429Titan Dental Design2Cleared 510(K)
- K223518iOrtho2Cleared 510(K)
- K212173HDH Treatment Planning System2Cleared 510(K)
- K212770Vision2Cleared 510(K)
- K213916ArchForm Orthodontic Software System2Cleared 510(K)
- K212828BRIUS Planner Software2Cleared 510(K)
- K203442Inbrace Orthodontic System2Cleared 510(K)
- K201036PlaniMax Orthodontic Software2Cleared 510(K)
- K192847AUTOLIGN2Cleared 510(K)
- K200772ULab Systems uDesign Software2Cleared 510(K)
- K193003NemoCast2Cleared 510(K)
- K192701DIBS (Digital Indirect Bonding System)2Cleared 510(K)
- K191720BRUIS Software Suite2Cleared 510(K)
- K193390CS Model+2Cleared 510(K)
- K1919113Shape Splint Design2Cleared 510(K)
- K183695OrthoAnalysis Software2Cleared 510(K)
- K181112Orchestrate 3D2Cleared 510(K)
- K180941Ortho System2Cleared 510(K)
- K171634Ortho System2Cleared 510(K)
- K171122CEREC Ortho Software2Cleared 510(K)
- K171295ULab Systems Treatment Planning Software2Cleared 510(K)
- K163677Ortho System2Cleared 510(K)
- K162850GuideMia Ortho+2Cleared 510(K)
- K1520863Shape Ortho System2Cleared 510(K)
- QCJClosed Loop Auto Titration Device For Oral Appliances2Product Code
- QJJIndirect Bonding Tray1Product Code
- QNONeuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea2Product Code
- QTTOver The Counter Electrical Salivary Stimulatory System2Product Code
- 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
3Shape Splint Design
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K191911
- 510(k) Type
- Traditional
- Applicant
- 3Shape A/S
- Country
- Denmark
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/27/2019
- Days to Decision
- 133 days
- Submission Type
- Summary