510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K200214Substantially Equivalent

3D Predict

3D Smile USA, Inc., Philadelphia PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200214 is the FDA 510(k) clearance record for 3D Predict, a class II device, cleared for 3D Smile USA, 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 one 510(k) clearance for 3D Smile USA, Inc. As of , FDA records show no recalls naming K200214.

Clearance record

Decision date
Received
(27 days to decision)
Product code
NXC Aligner, Sequential
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
3D Smile USA, Inc. 3675 Market St., Suite 200, Philadelphia PA
510(k) summary
Summary PDF
Third party review
Yes

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