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Perioview Model Dv-1 Fiberscope and Window Sheath.

by Dentalview, Inc.

510(k) K982480

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK982480 Date15 Sep 1998ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2530-2016 FDA Class II initiated 24 Jun 2016

    The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim.

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  • Withdrawn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
EIA
Device Class
Class I
Regulation
21 CFR Part 872.6640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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