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Dental Basics BE21

by Dental Basics Inc.

Dental Basics BE21 is a Class II device made by Dental Basics Inc., cleared under FDA 510(k) K163447 on 20 Jun 2017 and listed in FDA GUDID since 8 May 2024 (UDI-DI 00850061028006), active as of 22 Oct 2026.

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) K163447

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850061028006 UDI-DI Date8 May 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK163447 Date20 Jun 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K163447 decided 20 Jun 2017 Active
  • FDA GUDID UDI-DI 00850061028006 listed 8 May 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K163447
  2. Listed FDA GUDID 00850061028006

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dental Basics
Generic name
Digital imaging cassette
Model / reference
BE21
Primary DI / UDI-DI
00850061028006
510(k) Number
FDA product code
PEM
GMDN term
Digital imaging cassette
Device class
Class II
Regulation number
878.4370
GUDID distribution status
In Commercial Distribution

Related devices

Category: Digital imaging cassette

Cleared under the same submission (K163447)

and 8 more cleared under K163447

Other devices from Dental Basics Inc.

See all devices from Dental Basics Inc. →

Properties

  • Single use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)