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Hemo-Wedge

by Parker Laboratories, Inc.

510(k) K790555

Hemo-Wedge is a Class I device made by Parker Laboratories, Inc., cleared under FDA 510(k) K790555 on 17 Jan 1980, 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 NumberK790555 Date17 Jan 1980ClearedStatusActive

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  • Withdrawn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
DZN
Device class
Class I
Regulation
21 CFR Part 872.4565
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Devices cleared under K790555

7 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K790555
UDI-DISize and differences
Hemo-wedge 5020
Polydentia SA
5020E29950200 —On the market
Hemo-wedge 5021
Polydentia SA
5021E29950210 —On the market
Hemo-wedge 5022
Polydentia SA
5022E29950220 —On the market
Hemo-wedge 5023
Polydentia SA
5023E29950230 —On the market
Hemo-wedge 5024
Polydentia SA
5024E29950240 —On the market
Hemo-wedge 5025
Polydentia SA
5025E29950250 —On the market
Macro-Wedges 5030
Polydentia SA
5030E29950300 —On the market

Similar devices

Other devices filed under FDA product code DZN (Instruments, Dental Hand).

Other devices from Parker Laboratories, Inc.

See all devices from Parker Laboratories, Inc. →