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NADA Pumice Prophy Paste Box 200 223313

by Preventech

NADA Pumice Prophy Paste Box 200 223313 is a Class I device made by Preventech, cleared under FDA 510(k) K100539 on 17 Jun 2010 and listed in FDA GUDID since 13 Jun 2023 (UDI-DI D024223313), active as of 22 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 22 Oct 2026

Documents

510(k) K100539

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD024223313 UDI-DI Date13 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100539 Date17 Jun 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100539 decided 17 Jun 2010 Active
  • FDA GUDID UDI-DI D024223313 listed 13 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K100539
  2. Listed FDA GUDID D024223313

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
NADA Pumice Prophy Paste Box 200
Generic name
Dentifrice
Model / Ref / Catalog
223313
Primary DI / UDI-DI
D024223313
510(k) Number
FDA product code
EJR
GMDN term
Dentifrice
Device class
Class I
Regulation number
872.6030
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dentifrice

Cleared under the same submission (K100539)

and 8 more cleared under K100539

Similar devices in this category

Other devices filed under Dentifrice.

Other devices from Preventech

See all devices from Preventech →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)