Handpiece, Air-Powered, Root Canal Irrigation
The Handpiece, Air-Powered, Root Canal Irrigation (product code NYL) is a powered dental handpiece used to clean and irrigate the root canal prior to filling procedures in endodontic treatment. It is classified as FDA Class 1, subject to general controls, and regulated under 21 CFR 872.4200 within the Dental specialty. Third-party 510(k) review is available for this device type, and it carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NYL
- Device Class
- FDA class 1
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
Definition
To clean the root canal prior to filling and used for root canal irrigation.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K211721 | PS System | Dec 02, 2021 | Substantially Equivalent | Inter-Med, Inc. |
| K162436 | EndoVac Pure | Dec 21, 2016 | Substantially Equivalent | Kerr Corporation |
| K140685 | ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM | Jul 02, 2014 | Substantially Equivalent | Sybron Endo |
| K100606 | VATEA ENDONTIC IRRIGATION SYSTEM | May 28, 2010 | Substantially Equivalent | Redent Nova, Ltd. |
| K052271 | RINSENDO | May 26, 2006 | Substantially Equivalent | Air Techniques, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.