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Coe® 264010

by Gc America Inc. 2 variants

Coe 264010 is a dental impression tray (FDA Class I; FDA product code EBH, Material, Impression Tray, Resin) made by Gc America Inc., listed in FDA GUDID since 10 Feb 2017 (UDI-DI D6582640101), 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 NumberD6582640101 UDI-DI Date10 Feb 2017ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Coe®
Generic name
Dental impression tray, reusable
Model / Ref / Catalog
264010
Primary DI / UDI-DI
D6582640101
FDA product code
EBH
GMDN term
Dental impression tray, reusable
Device class
Class I
Regulation number
872.3670
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental impression tray, reusable

Similar devices

Other devices filed under FDA product code EBH (MATERIAL, IMPRESSION TRAY, RESIN).

Other devices from Gc America Inc.

See all devices from Gc America Inc. →

Properties

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