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DOA Kit, Element 5D Plus Lite 212202

by Align Technology Inc.

DOA Kit, Element 5D Plus Lite 212202 is a dental milling system (FDA Class II; FDA product code NTK, Caries Detector, Laser Light, Transmission) made by Align Technology Inc., cleared under FDA 510(k) K193659 on 20 Mar 2020 and listed in FDA GUDID since 4 Jun 2021 (UDI-DI 00816063021100), active as of 8 Nov 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 8 Nov 2026

Documents

510(k) K193659

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816063021100 UDI-DI Date4 Jun 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK193659 Date20 Mar 2020IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193659 decided 20 Mar 2020 Active
  • FDA GUDID UDI-DI 00816063021100 listed 4 Jun 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K193659
  2. Listed FDA GUDID 00816063021100

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DOA Kit, Element 5D Plus Lite
Generic name
Dental milling system, CAD/CAM, chairside
Model / reference
212202
Primary DI / UDI-DI
00816063021100
510(k) Number
FDA product code
NTK
GMDN term
Dental milling system, CAD/CAM, chairside
Device class
Class II
Regulation number
872.1745
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental milling system, CAD/CAM, chairside

Cleared under the same submission (K193659)

and 8 more cleared under K193659

Similar devices

Other devices filed under FDA product code NTK (Caries Detector, Laser Light, Transmission).

Other devices from Align Technology Inc.

See all devices from Align Technology Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)