Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- EASGel, Electrode, For Pulp Tester1Product Code
- EATTester, Pulp2Product Code
- EGZHolder, Film, X-Ray1Product Code
- EHAAligner, Beam, X-Ray1Product Code
- JEOMeasurer, Gingival Fluid1Product Code
- LFCDevice, Caries Detection2Product Code
- MVHDevice, Detection, Sulfide2Product Code
- NBLLaser, Fluorescence Caries Detection2Product Code
- NFPDevice, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders2Product Code
- NFQDevice, Dental Sonography, For Monitoring Jaw Sounds1Product Code
- NFRDevice, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders2Product Code
- NFSDevice, Jaw Tracking, For Monitoring Jaw Positions1Product Code
- NTKCaries Detector, Laser Light, Transmission2Product Code
- NYHPlaque Disclosing Kit2Product Code
- 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
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Gel, Electrode, For Pulp Tester
- Page Type
- Product Code
- Regulation Medical Specialty
- Dental
- Review Panel
- Dental
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 872.1730
- GMP Exempt?
- No
- 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 § 872.1730 Electrode gel for pulp testers
§ 872.1730 Electrode gel for pulp testers.
(a) Identification. An electrode gel for pulp testers is a device intended to be applied to the surface of a tooth before use of a pulp tester to aid conduction of electrical current.
(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 the limitations in § 872.9.
[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, 2001]