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
- K213159Encore System2Cleared 510(K)
- K201238Encore System2Cleared 510(K)
- K183310Encore System2Cleared 510(K)
- K133680ENCORE SYSTEM2Cleared 510(K)
- K121440ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT2Cleared 510(K)
- K121814ENCORE TONGUE SUSPENSION SYSTEM2Cleared 510(K)
- K111179ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN2Cleared 510(K)
- K110127PRELUDE III TONGUE SUSPENSION SYSTEM2Cleared 510(K)
- K103179PRELUDE II TOUNGE SUSPENSION SYSTEM2Cleared 510(K)
- K101060SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM2Cleared 510(K)
- OYHOrthodontic Vibratory Accessory2Product Code
- PLHOrthodontic Led Accessory2Product Code
- PNNOrthodontic Software2Product Code
- QCJClosed Loop Auto Titration Device For Oral Appliances2Product Code
- QJJIndirect Bonding Tray1Product 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
Encore System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K201238
- 510(k) Type
- Special
- Applicant
- Siesta Medical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/2/2020
- Days to Decision
- 148 days
- Submission Type
- Summary