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Zircon-F Prophylaxis Paste

by Pascal Co., Inc.

510(k) K040988

Zircon-F Prophylaxis Paste is a medical device (FDA Class I; FDA product code EJR, Agent, Polishing, Abrasive, Oral Cavity) made by Pascal Co., Inc., cleared under FDA 510(k) K040988 on 7 Jul 2004, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040988 Date7 Jul 2004ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
EJR
Device class
Class I
Regulation
21 CFR Part 872.6030
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code EJR (Agent, Polishing, Abrasive, Oral Cavity).

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