510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881331Substantially Equivalent

Orthodontic Nitinol Springs

Flexmedics, Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881331 is the FDA 510(k) clearance record for ORTHODONTIC NITINOL SPRINGS, a class I device, cleared for Flexmedics on under FDA product code EJW (Clasp, Wire). FDA records list 20 510(k) clearances for Flexmedics, from to . As of , FDA records show no recalls naming K881331.

Clearance record

Decision date
Received
(23 days to decision)
Product code
EJW Clasp, Wire
Regulation
21 CFR 872.3285
Device class
Class I
Review panel
Dental
Applicant
Flexmedics 620 Ford Ctr., 420 N. Fifth, Minneapolis MN
Third party review
No

Clearances, product code EJW

Trailing 12 months

FDA records hold no clearances under product code EJW in the trailing twelve months.

FDA records show no clearances under product code EJW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260