510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193659Substantially Equivalent

iTero Element 5D

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

K193659 is the FDA 510(k) clearance record for iTero Element 5D, a class II device, cleared for Align Technology, Inc. on under FDA product code NTK (Light Transmission Caries Detector). FDA records list 15 510(k) clearances for Align Technology, Inc., from to . As of , FDA records show no recalls naming K193659.

Clearance record

Decision date
Received
(81 days to decision)
Product code
NTK Light Transmission Caries Detector
Regulation
21 CFR 872.1745
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 NTK

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