510(k) K260356
- Device
- EndoColibri
- Applicant
- Koehrer Medical Engineering GmbH
- 510(k) number
- K260356
- Product code
- NYL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-10-29
- Date received
- 2026-02-03
- 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
- N
Applicant Contact#
- Contact
- Colleen Boswell
- Address
- Adolf-Flecken-Str. 10 North Rhine-Westphalia Neuss DE 41460 41460
FDA Registration Numbers#
- 3003361112
- 2024312
- 3012477813
- 3012494290
- 2133714
Source Documents#
Other 510(k) Records For Product Code NYL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K211721 | PS System | Inter-Med, Inc. | 2021-12-02 |
| 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 |