510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081960Substantially Equivalent

Invisalign System

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

K081960 is the FDA 510(k) clearance record for INVISALIGN SYSTEM, a class II device, cleared for Align Technology on under FDA product code NXC (Aligner, Sequential). FDA's definition for product code NXC reads: "The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion". FDA records list 15 510(k) clearances for Align Technology, from to . As of , FDA records show no recalls naming K081960.

Clearance record

Decision date
Received
(161 days to decision)
Product code
NXC Aligner, Sequential
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
Align Technology 881 Martin Ave., Santa Clara CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NXC

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