Skip to content

Polystar HK anteriors - shade D3

by Merz Dental GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

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 NumberD7091984663 UDI-DI Date15 Jan 2017ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
Polystar HK
Generic Name
Resin artificial teeth
Model / Ref / Catalog
anteriors, shade D3, mould 92 S, 1984663
Primary DI / UDI-DI
D7091984663
510(k) Number
FDA Product Code
ELM
GMDN Term
Resin artificial teeth
Models / Variants
shade D3
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

See all devices from Merz Dental GmbH →

Properties

  • Lot / Batch Number
  • Expiration Date

Other properties (12)

  • Sterile: 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