510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K262196Substantially Equivalent

Invisalign System

Align Technology, Inc., San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(88 days to decision)
Product code
PNN Orthodontic Software
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
Align Technology, Inc. 2820 Orchard Pkwy., San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PNN

Trailing 12 months
5 clearances under product code PNN in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PNN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260