510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200908Substantially Equivalent

iSMILE

3D Diagnostix Inc, Allston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200908 is the FDA 510(k) clearance record for iSMILE, a class II device, cleared for 3D Diagnostix, Inc. 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 2 510(k) clearances for 3D Diagnostix, Inc., from to . As of , FDA records show no recalls naming K200908.

Clearance record

Decision date
Received
(260 days to decision)
Product code
NXC Aligner, Sequential
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
3D Diagnostix, Inc. 24 Denby Rd., Allston MA
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