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
- K994357BITEM LOCK, MODELS SW006, SW0121Cleared 510(K)
- K932825MICROARCH GOLD BRACKET1Cleared 510(K)
- K933501ALASTIK1Cleared 510(K)
- K923372MEMORY WIRE1Cleared 510(K)
- K933080ORTHOTECH DURA-GOLD BARCKETS1Cleared 510(K)
- K935139FASCINATION CERAMIC BRACKET1Cleared 510(K)
- K936244REGENCY BRACKET1Cleared 510(K)
- K934881REFLECTIONS1Cleared 510(K)
- K935122DENTAURUM METAL BRACKETS1Cleared 510(K)
- K926427LARIAT PALATE EXPANDER1Cleared 510(K)
- K925028FORESTADENT ORTHODONTIC BANDS1Cleared 510(K)
- K930881CHANNEL-EDGE BRACKET SYSTEM1Cleared 510(K)
- K933758REGENCY PLUS BRACKET1Cleared 510(K)
- K922806ORMCO SPORTSGUARD1Cleared 510(K)
- K932025ION-IMPLANTED NEO SENTALLOY1Cleared 510(K)
- K925012PLASTIC CHAIN1Cleared 510(K)
- K923218NITANIUM PALATAL EXPANDER1Cleared 510(K)
- K931663NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL1Cleared 510(K)
- K930452SOLO TIES1Cleared 510(K)
- K924971FORESTADENT BRACKETS1Cleared 510(K)
- K923405THE HERBST APPLIANCE1Cleared 510(K)
- K923440APEX DIRECT BONDED BRACKETS1Cleared 510(K)
- K923709MEMORY WIRE1Cleared 510(K)
- K923261ORTHODONTIC METAL BRACKET1Cleared 510(K)
- K923432GERMAN MINI DYNALOCK1Cleared 510(K)
- K923029ORTHODONTIC STAINLESS STEEL BRACKET1Cleared 510(K)
- K923124GLENROE GOLDEN ORTHODONTIC BRACKET1Cleared 510(K)
- K922499REFLECTIONS - CERAMIC DENTAL BRACKET1Cleared 510(K)
- K920645ORTHODONTIC ELASTICS BANDS1Cleared 510(K)
- K914003MIDAS BRACKET1Cleared 510(K)
- K913913REFURBISHED ORTHODONTIC APPLIANCES1Cleared 510(K)
- K914616KLEER(TM) ORTHODONTIC BRACKET1Cleared 510(K)
- K911231ORTHODONTIC WIRE1Cleared 510(K)
- K912171PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE1Cleared 510(K)
- K910288NONSTAINING ALASTIKS1Cleared 510(K)
- K903498RETAINER, SCREW EXPANSION ORTHODONTIC1Cleared 510(K)
- K902809BRACKET, METAL, ORTHODOTNIC1Cleared 510(K)
- K904092LANCER ORIGINAL, SIERRA, GENERAL PURPOSE1Cleared 510(K)
- K904093BUCCAL TUBE, BUCCAL ATTACHMENT1Cleared 510(K)
- K904091TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO1Cleared 510(K)
- K904094C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE1Cleared 510(K)
- K904089PERMA MESH1Cleared 510(K)
- K903214OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS1Cleared 510(K)
- K902844NICKEL-TITANIUM ORTHODONTIC TOOTH SEPARATING SPRIN1Cleared 510(K)
- K902390AURA CERAMIC DENTAL APPLIANCE1Cleared 510(K)
- K901896ENDOMETRIAL SAMPLER1Cleared 510(K)
- K900678THE MYOLOC SYSTEM1Cleared 510(K)
- K902064MODIFIED UNI-STICK PLASTIC LIGATURE1Cleared 510(K)
- K902050BIOLASTIC SUPER ELASTIC ARCHES1Cleared 510(K)
- K900471FIBERBRAID(TM) BONDED RETAINER1Cleared 510(K)
- K901957MUSTANG, C.A.T.1Cleared 510(K)
- K900488MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE1Cleared 510(K)
- K900824FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM)1Cleared 510(K)
- K901024STAINLESS STEEL DENTAL WIRES AND CLASPS1Cleared 510(K)
- K900578SPORTS PACK ELASTICS1Cleared 510(K)
- K895854ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE)1Cleared 510(K)
- K900184LINGUAL SHEATH1Cleared 510(K)
- K895483ACME COATED ORTHODONTIC ARCHWIRE1Cleared 510(K)
- K891331UNI-STICK PLASTIC LIGATURES1Cleared 510(K)
- K893482KORN MANDIBULAR ADVANCER1Cleared 510(K)
- K894781OPTIFLEX1Cleared 510(K)
- K894358LUMINA ORTHODONTIC BRACKET1Cleared 510(K)
- K893655KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK1Cleared 510(K)
- K893555X-RING AND SPEED STIX PLASTIC LIGATURES1Cleared 510(K)
- K893550PLASTIC FORCE MODULE1Cleared 510(K)
- K893484MULTIPHASE ORTHODONTIC WIRE1Cleared 510(K)
- K893483BONDABLE RETAINER AND SPACE MAINTAINER1Cleared 510(K)
- K891982J1 ATTACHMENT (ORTHODONTIC APPLIANCE)1Cleared 510(K)
- K893654MEMORY CHAIN1Cleared 510(K)
- K893549X-RING SEPARATORS1Cleared 510(K)
- K893542DIASTEMA CLOSING KIT1Cleared 510(K)
- K892419NPG 2 BASE METAL ALLOY1Cleared 510(K)
- K892704GEM II ORTHODONTIC BRACKET1Cleared 510(K)
- K891775MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES1Cleared 510(K)
- K891599FILAFLEX ORTHODONTIC WIRE1Cleared 510(K)
- K890536JASPER JUMPER KIT1Cleared 510(K)
- K890656LIP BUMPER1Cleared 510(K)
- K891484ORTHODONTIC WRAP-AROUND HAWLEY RETAINER1Cleared 510(K)
- K891592ORTHODONTIC ARCH AND SURGICAL HOOKS1Cleared 510(K)
- K890581THE CLARK LIP SHIELD1Cleared 510(K)
- K89014520/20 ORTHODONTIC CERAMIC BRACKET1Cleared 510(K)
- K890529ALASTIGARD1Cleared 510(K)
- K885086TIN COATED NITI ORTHODONTIC ARCH WIRES1Cleared 510(K)
- K883120FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE1Cleared 510(K)
- K881789MINILINE BRACKET1Cleared 510(K)
- K874396OCO PREPARATIONS1Cleared 510(K)
- K881274CENTER BEND ARCH WIRES1Cleared 510(K)
- K881233STRAIGHT LENGTH ARCH WIRES1Cleared 510(K)
- K880882REVERSE CURVE ARCHWIRE1Cleared 510(K)
- K881163RECTANGULAR NITINOL ARCH WIRE1Cleared 510(K)
- K874226STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET1Cleared 510(K)
- K873649FLEX GOLD1Cleared 510(K)
- K870536GEM ORTHODONTIC BRACKET1Cleared 510(K)
- K852179CERAMIC ORTHODONIT APPLIANCE1Cleared 510(K)
- K852800A-COMPANY SELF-LIGATING APPLIANCE1Cleared 510(K)
- K844067VANISH ORTHODONTIC BRACKET1Cleared 510(K)
- K843143STABILIZING RETAINER1Cleared 510(K)
- K834272ALEXOLOK BRACKET1Cleared 510(K)
- K812300LINGUAL BRACKET1Cleared 510(K)
- K803316ORTHODONTIC BRACKET1Cleared 510(K)
- K801809ORTHODONTIC BRACKET/SPEED/HANSON SPEED1Cleared 510(K)
- K780170ORTHODONTIC BRACKET PADS1Cleared 510(K)
- K771774NEW BASE FOR ORTHODONTIC APPLIANCES1Cleared 510(K)
- 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
ION-IMPLANTED NEO SENTALLOY
- Page Type
- Cleared 510(K)
- 510(k) Number
- K932025
- 510(k) Type
- Traditional
- Applicant
- GAC INTL., INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/13/1993
- Days to Decision
- 140 days
- Submission Type
- Statement