The following data is part of a premarket notification filed by Nouvag Ag with the FDA for Contra-angle, Models 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,.
| Device ID | K022505 |
| 510k Number | K022505 |
| Device Name: | CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068, |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | NOUVAG AG REUSSWEHRSTRASSE 1 Gebenstorf, CH 5412 |
| Contact | Erich Forster |
| Correspondent | Erich Forster NOUVAG AG REUSSWEHRSTRASSE 1 Gebenstorf, CH 5412 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-29 |
| Decision Date | 2003-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| ENOU391529 | K022505 | 000 |
| ENOU5050NOU0 | K022505 | 000 |
| ENOU5051NOU0 | K022505 | 000 |
| ENOU5052NOU0 | K022505 | 000 |
| ENOU5053NOU0 | K022505 | 000 |
| ENOU5054NOU0 | K022505 | 000 |
| ENOU5057NOU0 | K022505 | 000 |
| ENOU5061NOU0 | K022505 | 000 |
| ENOU5065NOU0 | K022505 | 000 |
| ENOU5200NOU0 | K022505 | 000 |
| ENOU5201NOU0 | K022505 | 000 |
| ENOU5053MNOU0 | K022505 | 000 |
| ENOU17129 | K022505 | 000 |
| ENOU17779 | K022505 | 000 |
| ENOU391169 | K022505 | 000 |
| ENOU391179 | K022505 | 000 |
| ENOU391499 | K022505 | 000 |
| ENOU391509 | K022505 | 000 |
| ENOU18819 | K022505 | 000 |