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- 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
- 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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Frame, Rubber Dam
- Page Type
- Product Code
- Regulation Medical Specialty
- Dental
- Review Panel
- Dental
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 872.6300
- GMP Exempt?
- Yes
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 872.6300 Rubber dam and accessories
§ 872.6300 Rubber dam and accessories.
(a) Identification. A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.
[65 FR 2315, Jan. 14, 2000]