The following data is part of a premarket notification filed by Denplus, Inc. with the FDA for Impact-plus, Impact-20, Dp97, Dp97-20, Dp-pour And Dp-repair.
| Device ID | K991996 |
| 510k Number | K991996 |
| Device Name: | IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DENPLUS, INC. 4235 BEACONSFIELD Montreal, Quebec, CA H4a 2h4 |
| Contact | Shuojia Dong |
| Correspondent | Shuojia Dong DENPLUS, INC. 4235 BEACONSFIELD Montreal, Quebec, CA H4a 2h4 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-14 |
| Decision Date | 1999-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8451031217 | K991996 | 000 |
| D8451021309 | K991996 | 000 |
| D8451021300 | K991996 | 000 |
| D8451021200 | K991996 | 000 |
| D8451021100 | K991996 | 000 |
| D8451012200 | K991996 | 000 |
| D8451012100 | K991996 | 000 |
| D8451011317 | K991996 | 000 |
| D8451011316 | K991996 | 000 |
| D8451011309 | K991996 | 000 |
| D8451011307 | K991996 | 000 |
| D8451011305 | K991996 | 000 |
| D8451011304 | K991996 | 000 |
| D8451011303 | K991996 | 000 |
| D8451031101 | K991996 | 000 |
| D84510311010 | K991996 | 000 |
| D8451031102 | K991996 | 000 |
| D8451031216 | K991996 | 000 |
| D8451031207 | K991996 | 000 |
| D8451031205 | K991996 | 000 |
| D8451031204 | K991996 | 000 |
| D8451031203 | K991996 | 000 |
| D8451031202 | K991996 | 000 |
| D8451031201 | K991996 | 000 |
| D8451031117 | K991996 | 000 |
| D8451031116 | K991996 | 000 |
| D8451031107 | K991996 | 000 |
| D8451031105 | K991996 | 000 |
| D8451031104 | K991996 | 000 |
| D8451031103 | K991996 | 000 |
| D8451011302 | K991996 | 000 |
| D8451011301 | K991996 | 000 |
| D8451001316 | K991996 | 000 |
| D8451001309 | K991996 | 000 |
| D8451001307 | K991996 | 000 |
| D8451001303 | K991996 | 000 |
| D8451001302 | K991996 | 000 |
| D8451001300 | K991996 | 000 |
| D8451001216 | K991996 | 000 |
| D8451001207 | K991996 | 000 |
| D8451001202 | K991996 | 000 |
| D8451001200 | K991996 | 000 |
| D8451001116 | K991996 | 000 |
| D8451001107 | K991996 | 000 |
| D8451001102 | K991996 | 000 |
| D8451011101 | K991996 | 000 |
| D8451011102 | K991996 | 000 |
| D8451011103 | K991996 | 000 |
| D8451011217 | K991996 | 000 |
| D8451011216 | K991996 | 000 |
| D8451011207 | K991996 | 000 |
| D8451011205 | K991996 | 000 |
| D8451011204 | K991996 | 000 |
| D8451011203 | K991996 | 000 |
| D8451011202 | K991996 | 000 |
| D8451011201 | K991996 | 000 |
| D8451011117 | K991996 | 000 |
| D8451011116 | K991996 | 000 |
| D8451011107 | K991996 | 000 |
| D8451011105 | K991996 | 000 |
| D8451011104 | K991996 | 000 |
| D8451001100 | K991996 | 000 |
| D8451071316 | K991996 | 000 |
| D8451071116 | K991996 | 000 |
| D8451071107 | K991996 | 000 |
| D8451071105 | K991996 | 000 |
| D8451071104 | K991996 | 000 |
| D8451071103 | K991996 | 000 |
| D8451071102 | K991996 | 000 |
| D8451071101 | K991996 | 000 |
| D8451071100 | K991996 | 000 |
| D8451062200 | K991996 | 000 |
| D8451062100 | K991996 | 000 |
| D8451061316 | K991996 | 000 |
| D8451061309 | K991996 | 000 |
| D8451061307 | K991996 | 000 |
| D8451071200 | K991996 | 000 |
| D8451071201 | K991996 | 000 |
| D8451071202 | K991996 | 000 |
| D8451071309 | K991996 | 000 |
| D8451071307 | K991996 | 000 |
| D8451071305 | K991996 | 000 |
| D8451071304 | K991996 | 000 |
| D8451071303 | K991996 | 000 |
| D8451071302 | K991996 | 000 |
| D8451071301 | K991996 | 000 |
| D8451071300 | K991996 | 000 |
| D8451071216 | K991996 | 000 |
| D8451071207 | K991996 | 000 |
| D8451071205 | K991996 | 000 |
| D8451071204 | K991996 | 000 |
| D8451071203 | K991996 | 000 |
| D8451061305 | K991996 | 000 |
| D8451061304 | K991996 | 000 |
| D8451061102 | K991996 | 000 |
| D8451061101 | K991996 | 000 |
| D8451061100 | K991996 | 000 |
| D8451032200 | K991996 | 000 |
| D8451032100 | K991996 | 000 |
| D8451031317 | K991996 | 000 |
| D8451031316 | K991996 | 000 |
| D8451031309 | K991996 | 000 |
| D8451031307 | K991996 | 000 |
| D8451031305 | K991996 | 000 |
| D8451031304 | K991996 | 000 |
| D8451031303 | K991996 | 000 |
| D8451031302 | K991996 | 000 |
| D8451061103 | K991996 | 000 |
| D8451061104 | K991996 | 000 |
| D8451061105 | K991996 | 000 |
| D8451061303 | K991996 | 000 |
| D8451061302 | K991996 | 000 |
| D8451061301 | K991996 | 000 |
| D8451061300 | K991996 | 000 |
| D8451061216 | K991996 | 000 |
| D8451061207 | K991996 | 000 |
| D8451061205 | K991996 | 000 |
| D8451061204 | K991996 | 000 |
| D8451061203 | K991996 | 000 |
| D8451061202 | K991996 | 000 |
| D8451061200 | K991996 | 000 |
| D8451061116 | K991996 | 000 |
| D8451061107 | K991996 | 000 |
| D8451031301 | K991996 | 000 |