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Plasdent IC-20805

by Plasdent Corp.

Plasdent IC-20805 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 19 Jul 2022 (UDI-DI D832IC208051), 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 NumberD832IC208051 UDI-DI Date19 Jul 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 D832IC208051 listed 19 Jul 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201604
  2. Listed FDA GUDID D832IC208051

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  • Withdrawn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
Medical equipment/instrument drape, single-use
Model / Ref / Catalog
IC-20805
Primary DI / UDI-DI
D832IC208051
510(k) Number
FDA product code
PEM
GMDN term
Medical equipment/instrument drape, single-use
Device class
Class II
Regulation number
878.4370
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medical equipment/instrument drape, single-use

Cleared under the same submission (K201604)

and 8 more cleared under K201604

Similar devices in this category

Other devices filed under Medical equipment/instrument drape, single-use.

Other devices from Plasdent Corp.

See all devices from Plasdent Corp. →

Properties

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