Unit, Syringe, Air And/Or Water
The Dental Air and/or Water Syringe Unit is a dental device that delivers a controlled stream of air, water, or a combined air-water spray to the oral cavity, used to dry, rinse, and cool teeth and tissues during examination and dental procedures. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is ECB and the applicable regulation is 21 CFR 872.4565, under the Dental medical specialty.
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Basic Information
- Product Code
- ECB
- 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 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K942519 | UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS | Aug 23, 1994 | Substantially Equivalent | Bull Frog Mfg. Co. |
| K931772 | SURETIP SYRINGE TIP COVER | Mar 07, 1994 | Substantially Equivalent | Western M/D, Inc. |
| K931137 | DENTAL SYRINGE TIP | Nov 29, 1993 | Substantially Equivalent | A-Dec, Inc. |
| K923876 | RISKONTROL SINGLE USE | Apr 05, 1993 | Substantially Equivalent | Riskontrol |
| K923285 | PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE | Sep 15, 1992 | Substantially Equivalent | Smith & Nephew, Inc. |
| K920499 | SANI-TIP | May 03, 1992 | Substantially Equivalent | Dw Industries, Inc. |
| K911756 | POSTERIOR NASAL EPISTAXIS INSTRUMENTS | Oct 24, 1991 | Substantially Equivalent | Richard Wolf Medical Instruments Corp. |
| K890290 | BRACE (ORAFIX SPECIAL) | Mar 29, 1989 | Substantially Equivalent | Norcliff Thayer, Inc. |
| K863024 | SERINGA TRIPLICE S.L. | Sep 25, 1986 | Substantially Equivalent | Sds Dental, Inc. |
| K854699 | TUBING SYRING | Jan 06, 1986 | Substantially Equivalent | Almore Intl., Inc. |
| K801686 | SPACELINE THREE WAY SYRINGE | Aug 04, 1980 | Substantially Equivalent | Pacific Dental Corp. |
| K781594 | DENTAL WARM WATER IRRIGATING SYSTEM | Dec 04, 1978 | Substantially Equivalent | Rama Corp. |
FEI Numbers
This FDA classification entry is associated with 130 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 130 registration numbers. Click on an entry to view related FDA registrations.