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Hemo-wedge 5025

by Polydentia SA

Hemo-wedge 5025 is a Class I device made by Polydentia SA, cleared under FDA 510(k) K790555 on 17 Jan 1980 and listed in FDA GUDID since 1 Jul 2022 (UDI-DI E29950250), 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) K790555

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 NumberE29950250 UDI-DI Date1 Jul 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK790555 Date17 Jan 1980DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K790555 decided 17 Jan 1980 Active
  • FDA GUDID UDI-DI E29950250 listed 1 Jul 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K790555
  2. Listed FDA GUDID E29950250

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hemo-wedge
Generic name
Dental wedge, single-use
Model / reference
5025
Primary DI / UDI-DI
E29950250
510(k) Number
FDA product code
DZN
GMDN term
Dental wedge, single-use
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental wedge, single-use

Cleared under the same submission (K790555)

and 2 more cleared under K790555

Similar devices in this category

Other devices filed under Dental wedge, single-use.

Other devices from Polydentia SA

See all devices from Polydentia SA →

Properties

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