Syringe, Periodontic, Endodontic, Irrigating
The Periodontic and Endodontic Irrigating Syringe is a specialized dental syringe used to deliver irrigating solutions into the periodontal sulcus or root canal during periodontal and endodontic treatments, removing debris and reducing bacterial load. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EIC, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EIC
- 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 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K972234 | RCT GEL ROOT CANAL THERAPY GEL | Jun 30, 1997 | Substantially Equivalent | Dentsply Intl. |
| K864307 | MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI) | Nov 18, 1986 | Substantially Equivalent | Smith & Nephew, Inc. |
| K861846 | HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT | Jun 26, 1986 | Substantially Equivalent | Solar Dental Co., Inc. |
| K851944 | MAX-I-PROBE HANDPIECE | Jul 01, 1985 | Substantially Equivalent | Solo Pak Laboratories |
| K840237 | MAX-I-PROBE PERIODONTAL ENDODONTIC PROB | Apr 05, 1984 | Substantially Equivalent | Smith & Nephew, Mpl Division |
| K811889 | R & S SERIES FITTING TOOLS | Jul 24, 1981 | Substantially Equivalent | Suncoast Dental Corp. |
| K811594 | WATER PISTOL | Jul 15, 1981 | Substantially Equivalent | Aus-Tex Dental Mfg. & Design |
| K801484 | ROOT CANAL FILLING APPLICATOR NEEDLES | Jul 21, 1980 | Substantially Equivalent | National Patent Development Corp. |
| K801483 | MARK IV SYRINGE | Jul 21, 1980 | Substantially Equivalent | National Patent Development Corp. |
| K792578 | EPIC CANNULA | Jan 04, 1980 | Substantially Equivalent | Dental Development Services, Inc. |
| K792577 | ENDOVAGE SYRINGE | Jan 04, 1980 | Substantially Equivalent | Dental Development Services, Inc. |
| K792461 | CENTRIX MKIV ENDODONTIC DELIVERY | Dec 19, 1979 | Substantially Equivalent | Centrix, Inc. |
| K771406 | GUTTA GUN | Aug 26, 1977 | Substantially Equivalent | Aus-Tex Dental Mfg. & Design |
| K770967 | SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE | Jun 20, 1977 | Substantially Equivalent | National Patent Development Corp. |
| K770813 | ENDOGATOR | May 20, 1977 | Substantially Equivalent | Aus-Tex Dental Mfg. & Design |
| K770642 | SYRINGE, ENDODONTIC W/NOTCHED TIP NEEDLE | Apr 15, 1977 | Substantially Equivalent | National Patent Development Corp. |
FEI Numbers
This FDA classification entry is associated with 132 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 132 registration numbers. Click on an entry to view related FDA registrations.