Syringe, Irrigating (Dental)
The Dental Irrigating Syringe is a hand-held instrument used to flush water, saline, or antiseptic solutions into periodontal pockets, extraction sites, or other oral areas to cleanse debris, dilute bacteria, and promote healing. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EIB, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EIB
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K911118 | DTF-1000LL,DTF-1000 | Nov 20, 1991 | Substantially Equivalent | Cp Medical |
| K874543 | MODEL OPO-32 IRRIGATION SLEEVE | Jan 14, 1988 | Substantially Equivalent | Allergan, Inc. |
| K822411 | SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 | Jul 12, 1983 | Substantially Equivalent | Western Advanced Technology, Inc. |
| K760570 | ROBINSON MIDDLE EAR PROSTHESIS | Sep 21, 1976 | Substantially Equivalent | Xomed, Inc. |
FEI Numbers
This FDA classification entry is associated with 61 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 61 registration numbers. Click on an entry to view related FDA registrations.