Anesthesiology
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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
- K182118armor LC1Cleared 510(K)
- K151945Triumph Resin Dam1Cleared 510(K)
- K050318BARI-KAD PACKING DEVICE1Cleared 510(K)
- K043301GC TION GINGIVAL PROTECTOR1Cleared 510(K)
- K040797BRITESMILE MASKING CREAM1Cleared 510(K)
- K022522PULPDENT PUTTY DAM1Cleared 510(K)
- K021524LIGHT CURE DENTAL DAM1Cleared 510(K)
- K021613NIVEOUS LIQUID DAM1Cleared 510(K)
- K010935BRITESMILE BARRIER MATERIAL1Cleared 510(K)
- K983227POWER BLOCK1Cleared 510(K)
- K972775FASTDAM1Cleared 510(K)
- K961472DENTAL DAM SILICONE1Cleared 510(K)
- K954990DENTAL DAM1Cleared 510(K)
- K952628ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS1Cleared 510(K)
- K942992ROYAL SHIELD RUBBER DAMS1Cleared 510(K)
- K923157DENTAL RUBBER DAM1Cleared 510(K)
- K923163RUBBER DAM CLAMP1Cleared 510(K)
- K921771MINIDAM II1Cleared 510(K)
- K905470STANDARD RUBBER DAM WITH OR WITHOUT FRAMES1Cleared 510(K)
- K901236RUBBER, DENTAL DAM (NON-STERILE)1Cleared 510(K)
- K900844WEDJETS1Cleared 510(K)
- K894120MADEGOM LTDA. DENTAL DAM1Cleared 510(K)
- K885231KITCHIN DENTAL ABCESS DRAIN1Cleared 510(K)
- K890667RUBBER DAM1Cleared 510(K)
- K884828HANDIDAM1Cleared 510(K)
- K875255DREAM DAM1Cleared 510(K)
- K864096DREAM DAM1Cleared 510(K)
- K863816IVORY PREMIUM RUBBER DAM1Cleared 510(K)
- K852630DEN-MAT PAINT-ON RUBBER DAM1Cleared 510(K)
- K851045DENT-DR. VACU-FRAME1Cleared 510(K)
- K842844DENTI-D RUBBER DAM1Cleared 510(K)
- K833610DENTAL RUBBERDAM1Cleared 510(K)
- K780745RUBBER DAM1Cleared 510(K)
- 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
- 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
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- OphthalmicReview Panel
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ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K952628
- 510(k) Type
- Traditional
- Applicant
- ELASTOMADE ACCESSORIES SDN BHD
- Country
- Malaysia
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/19/1995
- Days to Decision
- 133 days
- Submission Type
- Summary