Anesthesiology
Review Panel
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- ChemistryReview Panel
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- 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
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- EAQDetector, Ultraviolet2Product Code
- DYNMouthpiece, Saliva Ejector1Product Code
- EBRUnit, Suction Operatory1Product Code
- EBZActivator, Ultraviolet, For Polymerization2Product Code
- ECCSterilizer, Glass Bead3Product Code
- ECGSterilizer, Boiling Water1Product Code
- EEAPlate, Base, Shellac1Product Code
- EEFClamp, Rubber Dam1Product Code
- EEGHeat Source For Bleaching Teeth1Product Code
- EEJGuard, Disk1Product Code
- EFCWarmer, Anesthetic Tube1Product Code
- EFHPaper, Articulation1Product Code
- EFNCotton, Roll1Product Code
- EFSUnit, Oral Irrigation1Product Code
- EFWToothbrush, Manual1Product Code
- EFXProtector, Silicate1Product Code
- EGDWax, Dental, Intraoral1Product Code
- EHJDisk, Abrasive1Product Code
- EHKCup, Prophylaxis1Product Code
- EHLPoint, Abrasive1Product Code
- EHMStrip, Polishing Agent1Product Code
- EHYTray, Impression, Preformed1Product Code
- EHZEvacuator, Oral Cavity1Product Code
- EIAUnit, Operative Dental1Product Code
- EIEDam, Rubber1Product Code
- EIHPowder, Porcelain2Product Code
- EJEFrame, Rubber Dam1Product Code
- EJGForceps, Rubber Dam Clamp1Product Code
- EJISyringe, Cartridge2Product Code
- EJQWheel, Polishing Agent1Product Code
- EJRAgent, Polishing, Abrasive, Oral Cavity1Product Code
- JEQToothbrush, Powered1Product Code
- JESFloss, Dental1Product Code
- JETPick, Massaging1Product Code
- JEWTip, Rubber, Oral Hygiene1Product Code
- KCQTube Impression And Matrix1Product Code
- KHRAbsorber, Saliva, Paper1Product Code
- KLCChair, Dental, With Operative Unit1Product Code
- K233921Luvis Chair (LC700C)1Cleared 510(K)
- K151987DCI Edge Dental Chair with Operative Unit1Cleared 510(K)
- K071353FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C1Cleared 510(K)
- K971063OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR1Cleared 510(K)
- K963209PROSTYLE COMPACT1Cleared 510(K)
- K942870ULTIMA 2 DENTAL CHAIR1Cleared 510(K)
- K940950KAVO SYSTEMATICA 10601Cleared 510(K)
- K925567E 4000 DENTAL OPERATING CHAIR1Cleared 510(K)
- K925119A-DEC 1040 CHAIR1Cleared 510(K)
- K923534PM2002 PROLINE1Cleared 510(K)
- K925319A-DEC 2182 DOCTOR'S UNIT1Cleared 510(K)
- K925318A-DEC 2181 DUO UNIT1Cleared 510(K)
- K925317A-DEC 2180 DUO UNIT, CUSP1Cleared 510(K)
- K925316A-DEC 2172 DOCTOR'S UNIT1Cleared 510(K)
- K925315A-DEC 2171 DUO UNIT1Cleared 510(K)
- K925314A-DEC 2170 DUO UNIT CUSP1Cleared 510(K)
- K925321A-DEC 2146 DUO UNIT1Cleared 510(K)
- K925325A-DEC 2185 DOCTOR'S UNIT1Cleared 510(K)
- K925324A-DEC 2184 DUO UNIT1Cleared 510(K)
- K925323A-DEC 2183 DUO UNIT, CUSP1Cleared 510(K)
- K925322A-DEC 2147 DOCTOR'S UNIT1Cleared 510(K)
- K925320A-DEC 2145 DUO UNIT, CUSP1Cleared 510(K)
- K931169MDT DENTAL CHAIR1Cleared 510(K)
- K923461PM2002 PROLINE, PM2002 PROLINE EC1Cleared 510(K)
- K922175HEALTHPAK CHAIR SOX BARRIERS1Cleared 510(K)
- K923306HEALTHPAK UTILITY SOX BARRIERS1Cleared 510(K)
- K920017IMPROVED DENTAL OPERATING LIGHT1Cleared 510(K)
- K920016IMPROVED DENTAL CHAIR1Cleared 510(K)
- K913535A-DEC DECADE 1020 CHAIR1Cleared 510(K)
- K913059A-DEC KNEEBREAK 1030 CHAIR1Cleared 510(K)
- K903454A-DEC DECADE 1010 CHAIR1Cleared 510(K)
- K903450A-DEC DECADE 1015 CHAIR1Cleared 510(K)
- K896602FD5000 DENTAL CHAIR1Cleared 510(K)
- K894060ESSE QUATTRO/ESSE UNO1Cleared 510(K)
- K893943FD 200 DENTAL STOOL1Cleared 510(K)
- K893944FD 300 DENTAL STOOL1Cleared 510(K)
- K893890FD4500 (DENTAL CHAIR)1Cleared 510(K)
- K893889FD3500 (DENTAL CHAIR)1Cleared 510(K)
- K893945FD 350 DENTAL STOOL1Cleared 510(K)
- K893946FD 400 DENTAL STOOL1Cleared 510(K)
- K893454CHAIR/STOOL UNIT DENTAL OPER., PORTABLE, FIELD1Cleared 510(K)
- K893045A-DEC PRIORITY 1005 CHAIR1Cleared 510(K)
- K884304ORTHO PATIENT CHAIR1Cleared 510(K)
- K884830DENTAL CHAIR F11Cleared 510(K)
- K883437DENTAL CHAIR1Cleared 510(K)
- K880475SKEMA (DENTAL UNIT)1Cleared 510(K)
- K880474AREA (DENTAL CHAIR)1Cleared 510(K)
- K863016DENTATUS L SET1Cleared 510(K)
- K863484SIEMENS SIRONA(R) DENTAL CHAIR1Cleared 510(K)
- K854647POLO DENTAL UNIT1Cleared 510(K)
- K854644MANTA DENTAL CHAIR1Cleared 510(K)
- K843233ANATOM SYSTEM1Cleared 510(K)
- K843436DENTAL CHAIR1Cleared 510(K)
- K822095HERPES-IHA KIT1Cleared 510(K)
- K822740K30000 DENTAL CHAIR1Cleared 510(K)
- K800276RITTER MODEL H COMPANION STOOL1Cleared 510(K)
- K800172SIROPORT1Cleared 510(K)
- K800084RITTER MODEL J DENTAL CHAIR1Cleared 510(K)
- K772300DENTAL CHAIR, VANGUARD1Cleared 510(K)
- K771873VISION SERIES DENTAL CHAIR1Cleared 510(K)
- K760599DENTAL CHAIRS1Cleared 510(K)
- K760404BI-CENTRIC SYSTEM1Cleared 510(K)
- K760322CHAIR, ATTACHED INSTRUMENT DEL. SYS.1Cleared 510(K)
- KMTTray, Fluoride, Disposable1Product Code
- KOJAirbrush2Product Code
- KOKSterilizer, Endodontic Dry Heat3Product Code
- LCNScraper, Tongue1Product Code
- MAUEraser, Dental Stain1Product Code
- MCFUnit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile1Product Code
- MMDToothbrush, Ionic, Battery-Powered1Product Code
- NOBUnit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile1Product Code
- NRDUnit, Operative Dental, Accessories1Product Code
- NRUChair, Dental, Without Operative Unit1Product Code
- NXVDiagnostic Light, Soft Tissue Detector2Product Code
- NXZDental Hygiene Kit1Product Code
- PIPProphy Powder, Airbrush Accessory2Product Code
- OFXGeneral Purpose Dental Tray1Product Code
- PFLIntraoral, Dental Foam Protector1Product Code
- QGOComposite Resin Warmer1Product Code
- QIAPowered Tongue Scraper1Product Code
- QJCPlaque Disclosing Agent1Product Code
- QMJPowered Radiofrequency Toothbrush2Product Code
- QNFLaser Activator For Polymerization2Product Code
- QYJDental Waterline Treatment Cartridge1Product Code
- Ear, Nose, ThroatReview Panel
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- 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
PM2002 PROLINE, PM2002 PROLINE EC
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K923461
- 510(k) Type
- Traditional
- Applicant
- PLANMECA USA, INC.
- Country
- Finland
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/21/1992
- Days to Decision
- 160 days
- Submission Type
- Statement