The following data is part of a premarket notification filed by Denplus, Inc. with the FDA for Hi-wave; Pour-plus.
| Device ID | K011762 |
| 510k Number | K011762 |
| Device Name: | HI-WAVE; POUR-PLUS |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DENPLUS, INC. 1221 LABADIE, SUITE 205 Longueuil, Quebec, CA J4n 1e2 |
| Contact | Shuojia Dong |
| Correspondent | Shuojia Dong DENPLUS, INC. 1221 LABADIE, SUITE 205 Longueuil, Quebec, CA J4n 1e2 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-07 |
| Decision Date | 2001-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8451152200 | K011762 | 000 |
| D8451142100 | K011762 | 000 |
| D8451141317 | K011762 | 000 |
| D8451141316 | K011762 | 000 |
| D8451141309 | K011762 | 000 |
| D8451141307 | K011762 | 000 |
| D8451141302 | K011762 | 000 |
| D8451141217 | K011762 | 000 |
| D8451141216 | K011762 | 000 |
| D8451141207 | K011762 | 000 |
| D8451141202 | K011762 | 000 |
| D8451141117 | K011762 | 000 |
| D8451141116 | K011762 | 000 |
| D8451141107 | K011762 | 000 |
| D8451142200 | K011762 | 000 |
| D8451151100 | K011762 | 000 |
| D8451151102 | K011762 | 000 |
| D8451152100 | K011762 | 000 |
| D8451151316 | K011762 | 000 |
| D8451151307 | K011762 | 000 |
| D8451151305SF0 | K011762 | 000 |
| D8451151305 | K011762 | 000 |
| D8451151302 | K011762 | 000 |
| D8451151300 | K011762 | 000 |
| D8451151205 | K011762 | 000 |
| D8451151202 | K011762 | 000 |
| D8451151200 | K011762 | 000 |
| D8451151116 | K011762 | 000 |
| D8451151107 | K011762 | 000 |
| D8451151105 | K011762 | 000 |
| D8451141102 | K011762 | 000 |