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Polystar HK anteriors - shade A1

by Merz Dental GmbH

Polystar HK anteriors - shade A1 is a Class II device made by Merz Dental GmbH, cleared under FDA 510(k) K030588 on 7 May 2003 and listed in FDA GUDID since 15 Jan 2017 (UDI-DI D7091984038), 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) K030588

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 NumberD7091984038 UDI-DI Date15 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK030588 Date7 May 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K030588 decided 7 May 2003 Active
  • FDA GUDID UDI-DI D7091984038 listed 15 Jan 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K030588
  2. Listed FDA GUDID D7091984038

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Polystar HK
Generic name
Resin artificial teeth
Model / Ref / Catalog
anteriors, shade A1, mould 96, 1984038
Primary DI / UDI-DI
D7091984038
510(k) Number
FDA product code
ELM
GMDN term
Resin artificial teeth
Models / Variants
shade A1
Device class
Class II
Regulation number
872.3590
GUDID distribution status
In Commercial Distribution

Related devices

Category: Resin artificial teeth

Cleared under the same submission (K030588)

and 8 more cleared under K030588

Other devices from Merz Dental GmbH

See all devices from Merz Dental GmbH →

Properties

  • Lot / batch number
  • Expiration date
Other properties (13, all answered No)