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Duray 3D Ceph

by Beyes Dental Canada Inc

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K213579

FDA submission, from GUDID

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 Number00990010312593 UDI-DI Date15 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213579 Date2 Mar 2022DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Duray
Generic name
Stationary panoramic dental x-ray system, digital
Model / reference
3D CEPH
Primary DI / UDI-DI
00990010312593
510(k) Number
FDA product code
OAS
GMDN term
Stationary panoramic dental x-ray system, digital
Device class
Class II
Regulation number
892.1750
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Cleared under the same submission (K213579)

Show all (9)

Other devices from Beyes Dental Canada Inc

  • Duray 2D

    Class II

  • Duray 3D

    Class II

  • Duray Art Plus

    Class II

  • Duray 2D Ceph

    Class II

  • Duray Art Plus C

    Class II

  • Beyes BR-1154

    Class I

See all devices from Beyes Dental Canada Inc →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date

Other properties (11)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Expiration date: No