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EdgeDam™ Refill Medium 5x5 Latex EDBLM5552

by Clinician's Choice Dental Products, Inc.

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 Number07540172019460 UDI-DI Date4 Jun 2024ListedStatusListed 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  • Withdrawn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
EdgeDam™ Refill Medium 5x5 Latex
Generic Name
Rubber dam, Hevea-latex
Model / Ref / Catalog
EDBLM5552
Primary DI / UDI-DI
07540172019460
FDA Product Code
EIE
GMDN Term
Rubber dam, Hevea-latex
Device Class
Class I
Regulation Number
872.6300
GUDID distribution status
In Commercial Distribution
Size
Area/Surface Area — 25 Square inch

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Properties

  • Single Use
  • Contains Latex
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No