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
- K112640HYPERELASTIC WIRE1Cleared 510(K)
- K943334HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT1Cleared 510(K)
- K935638NITINOL, NITI1Cleared 510(K)
- K935140DENTAURUM STEEL LIGATURE WIRES1Cleared 510(K)
- K935142DENTAURUM WIRES1Cleared 510(K)
- K934265FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE1Cleared 510(K)
- K933374NITI COIL SPRINGS1Cleared 510(K)
- K933377STAINLESS STEEL ARCHES REPACKER RELABETER1Cleared 510(K)
- K933379STAINLESS STEEL ARCHES1Cleared 510(K)
- K933376NITI ARCH WIRE ON A SPOOL1Cleared 510(K)
- K933378REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER1Cleared 510(K)
- K933380REVERSE SURVE NITI ARCH WIRE1Cleared 510(K)
- K931631COATED ORTHODONTIC DEVICES1Cleared 510(K)
- K930202TITAN SEPARATING SPRING1Cleared 510(K)
- K924805ORTHODONTIC ARCH WIRE1Cleared 510(K)
- K923837DIMPLED MULTI MODULUS ARCH WIRE1Cleared 510(K)
- K923836.016' X .016 NICKEL TITANIUM UPRIGHTING SPRING1Cleared 510(K)
- K923838THE ULTIMATE RCS ARCH WIRE1Cleared 510(K)
- K920905BIOFORCE WIRE1Cleared 510(K)
- K923839NITINOL GENTLE TOUCH COIL SPRING1Cleared 510(K)
- K920850GAC THUMB-SUCKING CONTROL APPLIANCE1Cleared 510(K)
- K863742FLEXMEDICS NITINOL ARCH WIRE1Cleared 510(K)
- K852975INTERPORE 200 POROUS HYDROXYAPATITE1Cleared 510(K)
- K851878A COMPANY BRASS SEPARATING RINGS1Cleared 510(K)
- K851055SENTINOL -ORTHODONTIC ARCH WIRE1Cleared 510(K)
- K843171FILAFEX TM, ESTHETIC ORTHODONTIC WIRE1Cleared 510(K)
- K843722ORTHODONTIC WIRE1Cleared 510(K)
- K841638ALINE ORTHODONTIC ARCHWIRE1Cleared 510(K)
- K833788FILAFEX ESTHETIC ORTHODINIC WIRE1Cleared 510(K)
- K812454PAC-AID1Cleared 510(K)
- 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
FILAFEX TM, ESTHETIC ORTHODONTIC WIRE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K843171
- 510(k) Type
- Traditional
- Applicant
- BERKLEY AND CO.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/3/1984
- Days to Decision
- 112 days