510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K163117Substantially Equivalent

Alpha Pure

Koroad America, Newport Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163117 is the FDA 510(k) clearance record for Alpha Pure, a class II device, cleared for Koroad America on under FDA product code NJM (Bracket, Ceramic, Orthodontic). FDA's definition for product code NJM reads: "An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position". FDA records list one 510(k) clearance for Koroad America. As of , FDA records show no recalls naming K163117.

Clearance record

Decision date
Received
(183 days to decision)
Product code
NJM Bracket, Ceramic, Orthodontic
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
Koroad America 895 Dove St., Suite 300, Newport Beach CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NJM

Trailing 12 months

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

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