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DCI Edge PJT604

by DCI International, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number10810021435173 UDI-DI Date10 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
DCI Edge
Generic Name
Dental surgical power tool motorized handpiece/set, pneumatic
Model / Reference
PJT604
Primary DI / UDI-DI
10810021435173
510(k) Number
FDA Product Code
EFB
GMDN Term
Dental surgical power tool motorized handpiece/set, pneumatic
Device Class
Class I
Regulation Number
872.4200
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K962540)

Other devices from DCI International, LLC

See all devices from DCI International, LLC →

Properties

  • Manufacturing Date

Other properties (13)

  • 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
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No