Knit-Pak+
by Premier Dental Products Co.
510(k) K132526
Knit-Pak+ is a medical device (FDA unclassified; FDA product code MVL, Cord, Retraction) made by Premier Dental Products Co., cleared under FDA 510(k) K132526 on 26 Nov 2013, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK132526 | Date26 Nov 2013 | StatusActive |
Official records
- FDA 510(k) database K132526
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MVL
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K132526
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Knit-Pak+ 9007560 | 9007560 | 00348783001792 | — | On the market |
| Knit-Pak+ 9007561 | 9007561 | 00348783001808 | — | On the market |
| Knit-Pak+ 9007562 | 9007562 | 00348783001815 | — | On the market |
| Knit-Pak+ 9007563 | 9007563 | 00348783001822 | — | On the market |
| Knit-Pak+ 9007564 | 9007564 | 00348783001839 | — | On the market |
| Knit-Pak+ 9007565 | 9007565 | 00348783001846 | — | On the market |
| Knit-Pak+ 9007569 | 9007569 | 00348783001853 | — | On the market |
| Sure-endo SCP-0 | SCP-0 | 08809264299968 | — | On the market |
| Sure-endo SCP-0 | SCP-0 | 08809264299449 | — | On the market |
| Sure-endo SCP-0/S50 | SCP-0/S50 | 08809264299685 | — | On the market |
| Sure-endo SCP-00 | SCP-00 | 08809264299951 | — | On the market |
| Sure-endo SCP-00 | SCP-00 | 08809264299432 | — | On the market |
| Sure-endo SCP-00/S50 | SCP-00/S50 | 08809264299678 | — | On the market |
| Sure-endo SCP-000 | SCP-000 | 08809264299944 | — | On the market |
| Sure-endo SCP-000 | SCP-000 | 08809264299425 | — | On the market |
| Sure-endo SCP-000.0 | SCP-000.0 | 08809264299883 | — | On the market |
| Sure-endo SCP-000.0 | SCP-000.0 | 08809264299418 | — | On the market |
| Sure-endo SCP-000.0/S50 | SCP-000.0/S50 | 08809264299654 | — | On the market |
| Sure-endo SCP-000/S50 | SCP-000/S50 | 08809264299661 | — | On the market |
| Sure-endo SCP-1 | SCP-1 | 08809264299456 | — | On the market |
| Sure-endo SCP-1 | SCP-1 | 08809264299975 | — | On the market |
| Sure-endo SCP-1/S50 | SCP-1/S50 | 08809264299692 | — | On the market |
| Sure-endo SCP-2 | SCP-2 | 08809264299463 | — | On the market |
| Sure-endo SCP-2 | SCP-2 | 08809264299982 | — | On the market |
| Sure-endo SCP-2/S50 | SCP-2/S50 | 08809264299708 | — | On the market |
Similar devices
Other devices filed under FDA product code MVL (Cord, Retraction).
- KORLEX-GR GINGIVAL RETRACTION PASTE by Biotech One, Inc.
- GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord by KERR CORPORATION
- HEMOSTASYL PASTE by Satelec
- RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE by PARKELL, INC.
- Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials by KERR CORPORATION
- One-Stop by MEDICLUS Co., Ltd.
- Retrax Solution 15 mL 15600 by PASCAL COMPANY, INC.
- CyClean Cord by SS Global
- ViscoStat Clear S646 by ULTRADENT PRODUCTS, INC.
- COSP2 by 3M Espe AG Dental Products