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
- K232827LightForce Orthodontic System2Cleared 510(K)
- K232011Cleo2Cleared 510(K)
- K231635A-Line Advanced2Cleared 510(K)
- K230225DynaFlex Clear Brackets & Buttons2Cleared 510(K)
- K222847Ceramic Brackets Orthometric2Cleared 510(K)
- K222764LightForce Orthodontic System2Cleared 510(K)
- K220689Vatech Clismile2Cleared 510(K)
- K201410VENUS Bracket, ROSE Bracket2Cleared 510(K)
- K201038Luce Ceramic Bracket2Cleared 510(K)
- K200148LightForce Orthodontic System (LFO System)2Cleared 510(K)
- K182672ROSA Bracket2Cleared 510(K)
- K192202Clear212Cleared 510(K)
- K190608Mei Ceramic Bracket2Cleared 510(K)
- K180952Ceramic Bracket2Cleared 510(K)
- K182193S-Line2Cleared 510(K)
- K183542Signature Orthodontic System2Cleared 510(K)
- K181271Signature Orthodontic System2Cleared 510(K)
- K1804043M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System2Cleared 510(K)
- K173440Carriere SLX 3D Clear2Cleared 510(K)
- K172845Symetri Clear2Cleared 510(K)
- K171844Inspire ICE aka Inspire ICE Clear Brackets2Cleared 510(K)
- K163467C-Line Orthodontic Ceramic Bracket2Cleared 510(K)
- K163117Alpha Pure2Cleared 510(K)
- K160957CDB Self Ligating Bracket 8F2Cleared 510(K)
- K160615ORTHODONTIC CERAMIC BRACKETS 1.12Cleared 510(K)
- K152167BIJOU Orthodontic Ceramic Bracket2Cleared 510(K)
- K152779Avex CX22Cleared 510(K)
- K150141Orthodontics Bracket2Cleared 510(K)
- K142729Chi Lites Orthodontic Sapphire Bracket2Cleared 510(K)
- K141104TRUKLEAR BRACKET2Cleared 510(K)
- K132368VAPOR CERAMIC BRACKET2Cleared 510(K)
- K131197EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS2Cleared 510(K)
- K130446FASTBRACES CERAMIC BRACKETS2Cleared 510(K)
- K123092CERAMIN BRACKETS Z2Cleared 510(K)
- K122753EMPOWER CLEAR2Cleared 510(K)
- K123094ORTHODONTIC CERAMIC BRACKETS2Cleared 510(K)
- K120471MACH BRACKETS BRIGHT BRACKETS2Cleared 510(K)
- K113334AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS2Cleared 510(K)
- K112707GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM2Cleared 510(K)
- K110335CERAMIC BRACKETS2Cleared 510(K)
- K111234CLICK-IT2Cleared 510(K)
- K102803CLARITY ADVANCED CERAMIC BRACKETS2Cleared 510(K)
- K102561ORTHODONTIC CERAMIC BRACKET2Cleared 510(K)
- K101481BIOMERS TRANSLUCENT ORTHODONTIC BRACKET2Cleared 510(K)
- K091702CDB FLIP-SIDE-CLIP BRACKET2Cleared 510(K)
- K090933BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS2Cleared 510(K)
- K090567ORTHODONTIC CERAMIC BRACKET2Cleared 510(K)
- K090454ALLURE MB CERAMIC BRACKETS2Cleared 510(K)
- K082974MYSTIQUE MB CERAMIC BRACKETS2Cleared 510(K)
- K080906CDB CLIP2Cleared 510(K)
- K081415DAMON 4CLEAR2Cleared 510(K)
- K080749RADIANCE2Cleared 510(K)
- K073045SAPPHIRE CERAMIC BRACKET2Cleared 510(K)
- K062305CLARITY MODIFIED CERAMIC BRACKETS2Cleared 510(K)
- K060837IN-OVATION C2Cleared 510(K)
- K052245ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS2Cleared 510(K)
- K042905NEO-CLIP ORTHODONTIC BRACKET ACCESSORY2Cleared 510(K)
- K042178ORTHODONTIC CERAMIC BRACKETS2Cleared 510(K)
- K950992CERAMAFLEX BRACKET SYSTEM2Cleared 510(K)
- K902075INTRIGUE CERAMIC BRACKET2Cleared 510(K)
- 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
- 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
ROSA Bracket
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K182672
- 510(k) Type
- Traditional
- Applicant
- GNI Co., LTD
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/15/2019
- Days to Decision
- 415 days
- Submission Type
- Summary