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Plasdent HP-COVR

by Plasdent Corp.

Plasdent HP-COVR is a Class II device made by Plasdent Corp., cleared under FDA 510(k) K201604 on 23 Dec 2020 and listed in FDA GUDID since 16 Jun 2022 (UDI-DI D832HPCOVR1), 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) K201604

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 NumberD832HPCOVR1 UDI-DI Date16 Jun 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201604 Date23 Dec 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201604 decided 23 Dec 2020 Active
  • FDA GUDID UDI-DI D832HPCOVR1 listed 16 Jun 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201604
  2. Listed FDA GUDID D832HPCOVR1

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Plasdent
Generic name
Surgical instrument protective cap
Model / Ref / Catalog
HP-COVR
Primary DI / UDI-DI
D832HPCOVR1
510(k) Number
FDA product code
PEM
GMDN term
Surgical instrument protective cap
Device class
Class II
Regulation number
878.4370
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical instrument protective cap

Cleared under the same submission (K201604)

and 8 more cleared under K201604

Other devices from Plasdent Corp.

See all devices from Plasdent Corp. →

Properties

  • Single use
  • Lot / batch number
Other properties (13, all answered No)