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Knit-Pak+ 9007563

by Premier Dental Products Company

Knit-Pak+ 9007563 is a gingival retraction cord (FDA unclassified; FDA product code MVL, Cord, Retraction) made by Premier Dental Products Company, cleared under FDA 510(k) K132526 on 26 Nov 2013 and listed in FDA GUDID since 9 Jan 2024 (UDI-DI 00348783001822), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K132526

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00348783001822 UDI-DI Date9 Jan 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK132526 Date26 Nov 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132526 decided 26 Nov 2013 Active
  • FDA GUDID UDI-DI 00348783001822 listed 9 Jan 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132526
  2. Listed FDA GUDID 00348783001822

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Knit-Pak+
Generic name
Gingival retraction cord, non-medicated
Model / reference
9007563
Primary DI / UDI-DI
00348783001822
510(k) Number
FDA product code
MVL
GMDN term
Gingival retraction cord, non-medicated
Device class
U
GUDID distribution status
In Commercial Distribution

Related devices

Category: Gingival retraction cord, non-medicated

Cleared under the same submission (K132526)

and 8 more cleared under K132526

Similar devices in this category

Other devices filed under Gingival retraction cord, non-medicated.

Other devices from Premier Dental Products Company

See all devices from Premier Dental Products Company →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)