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Invisalign Palatal Holder with Engagement Features 5028

by Align Technology, Inc.

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 Number00816063023425 UDI-DI Date29 Sep 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  • Withdrawn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
Invisalign Palatal Holder with Engagement Features
Generic Name
Orthodontic retainer
Model / Reference
5028
Primary DI / UDI-DI
00816063023425
510(k) Number
FDA Product Code
NXC, PNN
GMDN Term
Orthodontic retainer
Device Class
Class II
Regulation Number
872.5470
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K252931)

Other devices from Align Technology, Inc.

See all devices from Align Technology, Inc. →

Properties

  • Prescription Use
  • Manufacturing Date

Other properties (12)

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