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Eclipse® Eclipse Bonding Agent

by Dentsply International

Listed FDA GUDID listing, not in commercial distribution

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

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 NumberD0019055450 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Eclipse®
Generic Name
Dental appliance fabrication material, resin
Model / Ref / Catalog
Eclipse Bonding Agent, 905545
Primary DI / UDI-DI
D0019055450
FDA Product Code
KLE, EBI
GMDN Term
Dental appliance fabrication material, resin
Device Class
Class II
Regulation Number
872.3200, 872.3760
GUDID distribution status
Not in Commercial Distribution
Size
Weight — 180 Gram

Other devices from Dentsply International

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Properties

  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (11)

  • 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