510(k) K211721
- Device
- PS System
- Applicant
- Inter-Med, INC.
- 510(k) number
- K211721
- Product code
- NYL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-12-02
- Date received
- 2021-06-04
- Regulation
- 872.4200
- Classification name
- Handpiece, Air-powered, Root Canal Irrigation
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Brett Arand
- Address
- 2200 S. St. Racine WI US 53404 53404
FDA Registration Numbers#
- 3003361112
- 2024312
- 3012477813
- 3012494290
- 2133714
Source Documents#
Other 510(k) Records For Product Code NYL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260356 | EndoColibri | Koehrer Medical Engineering GmbH | 2026-10-29 |
| K162436 | EndoVac Pure | Kerr Corporation | 2016-12-21 |
| K140685 | ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM | Sybron Endo | 2014-07-02 |
| K100606 | VATEA ENDONTIC IRRIGATION SYSTEM | Redent Nova, Ltd. | 2010-05-28 |
| K052271 | RINSENDO | Air Techniques, Inc. | 2006-05-26 |
Legacy Summary#
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FDA Review#
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