510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130643Substantially Equivalent

Acceledent Aura

Orthoaccel Technologies, Inc., Bellaire TX / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130643 is the FDA 510(k) clearance record for ACCELEDENT AURA, a class II device, cleared for Orthoaccel Technologies, Inc. on under FDA product code OYH (Orthodontic Vibratory Accessory). FDA's definition for product code OYH reads: "An orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement". FDA records list 3 510(k) clearances for Orthoaccel Technologies, Inc., from to . As of , FDA records show no recalls naming K130643.

Clearance record

Decision date
Received
(43 days to decision)
Product code
OYH Orthodontic Vibratory Accessory
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
Orthoaccel Technologies, Inc. 6575 W. Loop S., Suite 200, Bellaire TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OYH

Trailing 12 months

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

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