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Royal 81001

by Danville Materials, LLC

Royal 81001 is a Class II device made by Danville Materials, LLC, listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00816594023789), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816594023789 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Royal
Generic name
Polyether dental impression material
Model / Ref / Catalog
81001
Primary DI / UDI-DI
00816594023789
FDA product code
ELW
GMDN term
Polyether dental impression material
Device class
Class II
Regulation number
872.3660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polyether dental impression material

Other devices from Danville Materials, LLC

See all devices from Danville Materials, LLC →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)