The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Knit-pak+.
| Device ID | K132526 |
| 510k Number | K132526 |
| Device Name: | KNIT-PAK+ |
| Classification | Cord, Retraction |
| Applicant | PREMIER DENTAL PRODUCTS CO. 1710 ROMANO DR. Plymouth Meeting, PA 19462 |
| Contact | Vincent D'allesandro |
| Correspondent | Vincent D'allesandro PREMIER DENTAL PRODUCTS CO. 1710 ROMANO DR. Plymouth Meeting, PA 19462 |
| Product Code | MVL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-12 |
| Decision Date | 2013-11-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809264299982 | K132526 | 000 |
| 00348783001808 | K132526 | 000 |
| 00348783001815 | K132526 | 000 |
| 00348783001822 | K132526 | 000 |
| 00348783001839 | K132526 | 000 |
| 00348783001846 | K132526 | 000 |
| 00348783001853 | K132526 | 000 |
| 08809264299418 | K132526 | 000 |
| 08809264299425 | K132526 | 000 |
| 08809264299432 | K132526 | 000 |
| 08809264299449 | K132526 | 000 |
| 08809264299456 | K132526 | 000 |
| 08809264299463 | K132526 | 000 |
| 08809264299883 | K132526 | 000 |
| 08809264299944 | K132526 | 000 |
| 08809264299951 | K132526 | 000 |
| 08809264299968 | K132526 | 000 |
| 08809264299975 | K132526 | 000 |
| 00348783001792 | K132526 | 000 |