510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K182658Substantially Equivalent

Bioliner

Five Star Orthodontic Lab & Supply, Denton TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182658 is the FDA 510(k) clearance record for Bioliner, a class II device, cleared for Five Star Orthodontic Lab & Supply 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 Five Star Orthodontic Lab & Supply. As of , FDA records show no recalls naming K182658.

Clearance record

Decision date
Received
(267 days to decision)
Product code
NXC Aligner, Sequential
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
Five Star Orthodontic Lab & Supply 2928 Metro St., Suite 102, Denton TX
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