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
- K233935DigiLine Direct Print Aligner System2Cleared 510(K)
- K240038Clear Moves Aligners2Cleared 510(K)
- K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX2Cleared 510(K)
- K240597TERA HARZ CLEAR2Cleared 510(K)
- K233544MESHEET2Cleared 510(K)
- K232074Serafin®2Cleared 510(K)
- K232887Invisalign Palatal Expander System2Cleared 510(K)
- K230199Byte Aligner System2Cleared 510(K)
- K2332573M™ Clarity™Aligners with Quick Attachments2Cleared 510(K)
- K232233Invisalign System with Mandibular Advancement Featuring Occlusal Blocks2Cleared 510(K)
- K231884TRIOCLEAR System2Cleared 510(K)
- K223517Clear Aligner2Cleared 510(K)
- K2314643M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)2Cleared 510(K)
- K223141STR8 Clear Aligner2Cleared 510(K)
- K223454Custom-made Invisible Aligners2Cleared 510(K)
- K221537Nightwear Aligners2Cleared 510(K)
- K222619Ensmile2Cleared 510(K)
- K221845Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G2Cleared 510(K)
- K223338Toothsi, Smilealigners2Cleared 510(K)
- K222894Invisalign System, Pre-Formed Attachment System2Cleared 510(K)
- K222308Al Smile Aligner2Cleared 510(K)
- K222918DentCare Aligners2Cleared 510(K)
- K223355Tera Harz Clear2Cleared 510(K)
- K211427CREOKORREKT Aligners2Cleared 510(K)
- K222418Nuvola2Cleared 510(K)
- K220140ClearCorrect System2Cleared 510(K)
- K221475MyClearALIGN Dental Aligner System2Cleared 510(K)
- K213026Clear Aligner2Cleared 510(K)
- K220835Arkligners2Cleared 510(K)
- K221097SmileSeries2Cleared 510(K)
- K203624Custom-made Invisible Aligners2Cleared 510(K)
- K212680LuxCreo Clear Aligner System2Cleared 510(K)
- K212803DailyMate Orthodontic Aligner System2Cleared 510(K)
- K220287Invisalign System2Cleared 510(K)
- K220726K Clear2Cleared 510(K)
- K211510uLab Systems Dental Aligner Kit2Cleared 510(K)
- K213297Redline2Cleared 510(K)
- K212772Precision Align2Cleared 510(K)
- K212496Ortho Aligner System2Cleared 510(K)
- K211537QuickAligners2Cleared 510(K)
- K203688Clear Aligner2Cleared 510(K)
- K210763Inman Digital Clear Aligners2Cleared 510(K)
- K212660Smylio Invisible Clear Aligners2Cleared 510(K)
- K212961SMILERS2Cleared 510(K)
- K210373Clear Aligners2Cleared 510(K)
- K210320ClearCorrect System2Cleared 510(K)
- K193622TRIOCLEAR System2Cleared 510(K)
- K210613HIT Clear Aligner2Cleared 510(K)
- K2106526MS Invisible Aligner2Cleared 510(K)
- K210540Ohlendorf Clear Aligner2Cleared 510(K)
- K211010Illusion Aligners2Cleared 510(K)
- K2111903M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)2Cleared 510(K)
- K203737Spark Clear Aligner System2Cleared 510(K)
- K201104AsoAligner2Cleared 510(K)
- K173738Archworx2Cleared 510(K)
- K202792BRIUS Clear Aligners2Cleared 510(K)
- K203339NEOLab Clear Aligners2Cleared 510(K)
- K202857ClearPath Aligner2Cleared 510(K)
- K200908iSMILE2Cleared 510(K)
- K193385TP Orthodontics Clear Aligner System2Cleared 510(K)
- K200005Concinnity Aligners2Cleared 510(K)
- K202685Eon Aligner2Cleared 510(K)
- K201450Straight T Clear Dental Aligner2Cleared 510(K)
- K193130MVP Aligner System2Cleared 510(K)
- K192244Arcad SmileStudio and Aligner System2Cleared 510(K)
- K192069Aerodentis System2Cleared 510(K)
- K191308U-Aligner2Cleared 510(K)
- K191838Clearform Aligners2Cleared 510(K)
- K192338NEOLab Clear Aligners2Cleared 510(K)
- K2002143D Predict2Cleared 510(K)
- K192596ULab Systems Dental Aligner Kit2Cleared 510(K)
- K192846Argen Clear Aligner, Argen Clear Aligner Premium2Cleared 510(K)
- K191837UniSmile Clear Aligner System2Cleared 510(K)
- K192767Clear Aligner2Cleared 510(K)
- K192470DenMat Orthodontic Aligners2Cleared 510(K)
- K191823Clear-Aligners2Cleared 510(K)
- K182388Krystal Klear Aligners2Cleared 510(K)
- K190394SunClear Aligner system2Cleared 510(K)
- K190003Vivid Aligners2Cleared 510(K)
- K191774SmileAlign Orthodontic Aligner System2Cleared 510(K)
- K1921193M Clarity Aligners2Cleared 510(K)
- K191990OSW Aligner System2Cleared 510(K)
- K190583DynaFlex2Cleared 510(K)
- K182658Bioliner2Cleared 510(K)
- K183229Argen Clear Aligner2Cleared 510(K)
- K190948Magic Clear Aligners2Cleared 510(K)
- K181747Orthodontic Appliance2Cleared 510(K)
- K180346Byte Aligner System2Cleared 510(K)
- K180648Park Dental Research Aligners2Cleared 510(K)
- K183643Clear Image Aligners2Cleared 510(K)
- K1831593M Clarity Aligners2Cleared 510(K)
- K182329SureCure Orthodontic Aligner System2Cleared 510(K)
- K181739Invisalign System with Mandibular Advancement Feature2Cleared 510(K)
- K182826Ormco Spark Aligner System2Cleared 510(K)
- K180241Orthocaps Twinaligner2Cleared 510(K)
- K173784Smylic Invisible Clear Aligners2Cleared 510(K)
- K172765Smart Moves Complete2Cleared 510(K)
- K173785Custom Clear Aligner System2Cleared 510(K)
- K180107Blue Sky Bio Aligner2Cleared 510(K)
- K171674Angel Align System2Cleared 510(K)
- K171860Sureclear aligners2Cleared 510(K)
- K162609ClearPath Aligner2Cleared 510(K)
- K163155MTM Clear Aligner2Cleared 510(K)
- K1636893M Clear Tray Aligner2Cleared 510(K)
- K151965Dentti System2Cleared 510(K)
- K143630Invisalign System2Cleared 510(K)
- K143499eCligner2Cleared 510(K)
- K123514CLEARPATH ALIGNER2Cleared 510(K)
- K132145MTM(R) CLEAR ALIGNER2Cleared 510(K)
- K123925MTM CLEAR ALIGNER IN-OFFICE2Cleared 510(K)
- K130237PONTIC PAINT2Cleared 510(K)
- K121396DYNAFLEX2Cleared 510(K)
- K113618CLEARCORRECT SYSTEM2Cleared 510(K)
- K093821FS ALIGNER2Cleared 510(K)
- K073121NUBRACE INVISIBLE REMOVABLE ORTHODONTICS2Cleared 510(K)
- K082556CLEARCORRECT2Cleared 510(K)
- K081960INVISALIGN SYSTEM2Cleared 510(K)
- K080246COMPOSITE ALIGNER BUTTON2Cleared 510(K)
- K071970CLEAR IMAGE ALIGNER2Cleared 510(K)
- K040874RED, WHITE & BLUE2Cleared 510(K)
- K981095ALIGN SYSTEM2Cleared 510(K)
- 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
- 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
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K221845
- 510(k) Type
- Abbreviated
- Applicant
- Blue Sky Bio, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/24/2023
- Days to Decision
- 245 days
- Submission Type
- Summary