510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942492Substantially Equivalent

Adjustable Bite Corrector

Orthoplus, Inc., Santa Rosa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942492 is the FDA 510(k) clearance record for ADJUSTABLE BITE CORRECTOR, a class I device, cleared for Orthoplus, Inc. on under FDA product code ECO (Spring, Orthodontic). FDA records list one 510(k) clearance for Orthoplus, Inc. As of , FDA records show no recalls naming K942492.

Clearance record

Decision date
Received
(49 days to decision)
Product code
ECO Spring, Orthodontic
Regulation
21 CFR 872.5410
Device class
Class I
Review panel
Dental
Applicant
Orthoplus, Inc. 1275 Fourth St., Suite 381, Santa Rosa CA
510(k) summary
Statement
Third party review
No

Clearances, product code ECO

Trailing 12 months

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

FDA records show no clearances under product code ECO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ECO, 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