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
- K251196Composite Orthodontic Brackets and Buttons2Cleared 510(K)
- K201940Braces on Demand Bracket2Cleared 510(K)
- K182338Blue Sky Bio Computerized Orthodontic Bracket System2Cleared 510(K)
- K180718ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES2Cleared 510(K)
- K160720Carriere Motion Clear Class II2Cleared 510(K)
- K150830CompleClear Plastic Orthodontic Bracket and Wire Appliance2Cleared 510(K)
- K150702Exceed Tx2Cleared 510(K)
- K140807COMPOSITE ORTHODONTIC BRACKETS2Cleared 510(K)
- K123118INSIGNIA DIGICAST2Cleared 510(K)
- K123416INSIGNIA WITH ITERO2Cleared 510(K)
- K121524INSIGNIA2Cleared 510(K)
- K110796SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE2Cleared 510(K)
- K101676CLEARARCH2Cleared 510(K)
- K082207ORTHOCAD IQ2Cleared 510(K)
- K092030ELATION MB METAL REINFORCED PLASTIC BRACKET2Cleared 510(K)
- K081143BIOMERS TRANSLUCENT ORTHODONTIC WIRE2Cleared 510(K)
- K071055OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 28022Cleared 510(K)
- K061042LINGLOCK2Cleared 510(K)
- K051953EVERSTICK A&O2Cleared 510(K)
- K053055ORTHODONTIC POLYMER COMPOSITE BRACKET2Cleared 510(K)
- K052477DAMON 3 MODIFIED2Cleared 510(K)
- K052370CP BRACKET SYSTEM2Cleared 510(K)
- K052714RAVE COMPOSITE BRACKET2Cleared 510(K)
- K050730MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM2Cleared 510(K)
- K032625ORTHODONTIC COMPOSITE BRACKET SYSTEM2Cleared 510(K)
- K032408DAMON FT2Cleared 510(K)
- K981433ORTHODONTIC BRACES2Cleared 510(K)
- K973776REFLECTIONS2Cleared 510(K)
- K955333SPIRIT MB2Cleared 510(K)
- K951239GLOWING SPIRITS2Cleared 510(K)
- K942826ORTHODONITC METAL REINFORCED PLASTIC BRACKET2Cleared 510(K)
- K944286METAL-LINED TRANSCEND CERAMIC BRACKET2Cleared 510(K)
- K943245SPIRIT MB2Cleared 510(K)
- K932920GLENROE PLASTIC BRACKET2Cleared 510(K)
- K900809LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS2Cleared 510(K)
- K896913SPIRIT2Cleared 510(K)
- K891372ORTHODONTIC PLASTIC BRACKET2Cleared 510(K)
- K874227PLASTIC BRACKETS2Cleared 510(K)
- K861965UNITEK CERAMIC BRACKET SYSTEM2Cleared 510(K)
- K802899CERAMIBOND2Cleared 510(K)
- K780239BRACKET, METAL REINFORCED PLASTIC2Cleared 510(K)
- 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
- 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
INSIGNIA
- Page Type
- Cleared 510(K)
- 510(k) Number
- K121524
- 510(k) Type
- Traditional
- Applicant
- ORMCO CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/9/2012
- Days to Decision
- 78 days
- Submission Type
- Summary