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Rhea Flat Plane Splint JFPRS

by Great Lakes Dental Technologies

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD775JFPRS0 UDI-DI Date10 May 2026ListedStatusListed 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  • Withdrawn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
Rhea Flat Plane Splint
Generic Name
Dental appliance fabrication material, resin
Model / Reference
JFPRS
Primary DI / UDI-DI
D775JFPRS0
FDA Product Code
EBI
GMDN Term
Dental appliance fabrication material, resin
Device Class
Class II
Regulation Number
872.3760
GUDID distribution status
In Commercial Distribution

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No