Probe, Periodontic
The Periodontic Probe is a slender, calibrated hand instrument used to measure the depth of the gingival sulcus and periodontal pockets around teeth, aiding in the diagnosis and monitoring of periodontal disease. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EIX, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EIX
- Device Class
- FDA class 1
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K960245 | VIP VICTOR INTERACTIVE PROBE | Apr 04, 1996 | Substantially Equivalent | Pro-Dentec |
| K944848 | THE VIVACARE T.P.S. PROBE | Dec 14, 1994 | Substantially Equivalent | Rms Div. |
| K936221 | PROBE TIP/PERI PROBE/PERI PROBE COMP. | Aug 01, 1994 | Substantially Equivalent | Pd International AB |
| K890333 | ALBUMIN REAGENT | Feb 17, 1989 | Substantially Equivalent | Alpkem Corp. |
| K880827 | ACCUTEK PERIODONTAL PROBE | Apr 12, 1988 | Substantially Equivalent | Sweet Micro Systems, Inc. |
| K875076 | FLORIDA PROBE | Mar 10, 1988 | Substantially Equivalent | Florida Probe Corp. |
| K870280 | ACCUDENT ACCUPROBE | Jun 08, 1987 | Substantially Equivalent | Accudent, Inc. |
| K871504 | DISPOSABLE PERIODONTAL PROBE | May 06, 1987 | Substantially Equivalent | Periodontal Health Brush, Inc. |
| K823324 | DENTAL INSTRUMENTS - PROBES | Nov 24, 1982 | Substantially Equivalent | Miltex, Inc. |
FEI Numbers
This FDA classification entry is associated with 159 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 159 registration numbers. Click on an entry to view related FDA registrations.