Anesthesiology
Review Panel
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- ChemistryReview Panel
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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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Device, Detection, Sulfide
- Page Type
- Product Code
- Regulation Medical Specialty
- Dental
- Review Panel
- Dental
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 872.1870
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 872.1870 Sulfide detection device
§ 872.1870 Sulfide detection device.
(a) Identification. A sulfide detection device is a device consisting of an AC-powered control unit, probe handle, probe tips, cables, and accessories. This device is intended to be used in vivo, to manually measure periodontal pocket probing depths, detect the presence or absence of bleeding on probing, and detect the presence of sulfides in periodontal pockets, as an adjunct in the diagnosis of periodontal diseases in adult patients.
(b) Classification. Class II (special controls) prescription use in accordance with § 801.109 of this chapter; conformance with recognized standards of biocompatibility, electrical safety, and sterility; clinical and analytical performance testing, and proper labeling.
[63 FR 59717, Nov. 5, 1998]