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Polystar HK anteriors; shade A1; mould 96

by Merz Dental GmbH

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
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)

Show all (12)

Other devices from Merz Dental GmbH

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Properties

  • Lot / batch number
  • Expiration date

Other properties (13)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No