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
- K202855Orthodontic Facemask2Cleared 510(K)
- K162543Reverse Pull Adjustable Facemask2Cleared 510(K)
- K111169PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF2Cleared 510(K)
- K103019KJ MASK2Cleared 510(K)
- K052553NITOM LOCKING FACEBOW2Cleared 510(K)
- K051751EQUA-PULL SAFETY RELEASE MODULE2Cleared 510(K)
- K041718KELES FACEMASK2Cleared 510(K)
- K032392MORALES PROTRACTION FACEMASK2Cleared 510(K)
- K000358MULTI ADJUSTABLE FACE MASK2Cleared 510(K)
- K993224T-GEAR, MODEL TG/400-7002Cleared 510(K)
- K982088AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM2Cleared 510(K)
- K980436CLASS III REVERSE PULL FACEMASK2Cleared 510(K)
- K980245NITOM LOCKING FACEBOW2Cleared 510(K)
- K980151RELEASABLE FORCE MODULE2Cleared 510(K)
- K980195FACEBOW2Cleared 510(K)
- K961754SAFETY RELEASE MODULE2Cleared 510(K)
- K955528CLP BONNET2Cleared 510(K)
- K950121FRANCE ORTHODONTIE2Cleared 510(K)
- K936151EXTRAORAL HEADGEAR2Cleared 510(K)
- K940410NEW GEAR RELEASABLE HEADGEAR2Cleared 510(K)
- K932761SOFT-WEAR HEADGEAR AND SAFETY MODULES2Cleared 510(K)
- K925240FACEBOW2Cleared 510(K)
- K923556ADP FACEMASK2Cleared 510(K)
- K920784ORTHODONTIC FACE BOW W/ INNER WIRE2Cleared 510(K)
- K912682ORTHODONTIC HEADGEAR2Cleared 510(K)
- K902646HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP2Cleared 510(K)
- K902645HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL2Cleared 510(K)
- K901958GUARDIAN SAFE BOW2Cleared 510(K)
- K862538SENTRY BREAKWAY NECK STRAP2Cleared 510(K)
- K861424ADAPTABLE CLASS III MASK2Cleared 510(K)
- K852670A-COMPANY ESPREE SAFETY HEADGEAR2Cleared 510(K)
- K800748SNAP-WAY HEADGEAR2Cleared 510(K)
- K790843SNAP-WAY2Cleared 510(K)
- K780747SNAP-WAY2Cleared 510(K)
- K771706SAIF-BOW2Cleared 510(K)
- K771095J HOOK HEADGEAR2Cleared 510(K)
- 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
AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM
- Page Type
- Cleared 510(K)
- 510(k) Number
- K982088
- 510(k) Type
- Traditional
- Applicant
- ORTHO KINETICS CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/4/1998
- Days to Decision
- 81 days
- Submission Type
- Statement