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510(k) K132526

KNIT-PAK+ by Premier Dental Products Co. — Product Code MVL

K132526 is an FDA 510(k) premarket notification submitted by Premier Dental Products Co. for the device "KNIT-PAK+". The FDA issued a decision of Substantially Equivalent on November 26, 2013. The device falls under product code MVL (Cord, Retraction), a Class U device. Premier Dental Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2013
Date Received
August 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cord, Retraction
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances by Premier Dental Products Co.

  • K260682 — Bond-PR™ Universal Adhesive (March 3, 2026)
  • K253513 — MultiMatch Flow Chameleon AntiMicrobial Composite (November 7, 2025)
  • K223632 — Premier's MultiMatch Universal Chameleon Restorative Composite (December 6, 2022)
  • K141839 — PREMIER ETCH (November 17, 2014)
  • K131212 — PREMIER CERAMIC PRIMER (August 26, 2013)
  • K083695 — TRAXODENT (April 28, 2009)
  • K062683 — ENAMEL PRO VARNISH (November 21, 2006)
  • K062166 — ENAMEL PRO (November 21, 2006)
  • K061998 — PREMIER SELF-ETCHING BOND ENHANCER (October 4, 2006)
  • K061997 — PREMIER SELF-ETCHING ENAMEL SEALANT (October 4, 2006)

Other clearances for product code MVL

  • K254239 — CyClean Cord (March 27, 2026)
  • K253797 — One-Stop (February 27, 2026)
  • K243910 — Retraxil (September 24, 2025)
  • K211420 — Stasis Gel (March 14, 2022)
  • K211419 — Gingi-Aid Gel (January 10, 2022)
  • K213149 — VOCO Retraction Paste (December 9, 2021)
  • K200764 — STATSTIX (October 15, 2020)
  • K193389 — Vista Clear (March 4, 2020)
  • K190220 — Vista FS, Vista FS Liquid (June 10, 2019)
  • K171577 — Smartcord, Smartcord X (May 3, 2018)

FDA data resources