KNIT-PAK+
FDA 510(k) clearance K132526 · decided 2013-11-26
Clearance details
- K-number
- K132526
- Device name
- KNIT-PAK+
- Applicant
- Premier Dental Products Co.
- Decision
- Substantially Equivalent
- Date received
- 2013-08-12
- Decision date
- 2013-11-26
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- MVL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Plymouth Meeting, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Premier Dental Products Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CyClean Cord (K254239) | SS GLOBAL | 2026-03-27 |
| One-Stop (K253797) | Mediclus Co., Ltd. | 2026-02-27 |
| Retraxil (K243910) | Kulzer, LLC | 2025-09-24 |
| Stasis Gel (K211420) | Belport Company, Inc., Gingi-Pak | 2022-03-14 |
| Gingi-Aid Gel (K211419) | Belport Company, Inc., Gingi-Pak | 2022-01-10 |
| VOCO Retraction Paste (K213149) | Voco GmbH | 2021-12-09 |
| STATSTIX (K200764) | Centrix Incorporated | 2020-10-15 |
| Vista Clear (K193389) | Inter-Med/Vista Dental Products | 2020-03-04 |
| Vista FS, Vista FS Liquid (K190220) | Inter-Med/Vista Dental Products | 2019-06-10 |
| Smartcord, Smartcord X (K171577) | Eastdent Co., Ltd. | 2018-05-03 |
| GingiDent Gingival Retraction Paste (K162662) | Pac-Dent International, Inc. | 2017-10-20 |
| Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials (K162948) | Kerr Corporation | 2017-08-08 |
Recalls involving this device
No recalls on record reference this clearance.