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 |