510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K052714Substantially Equivalent

Rave Composite Bracket

FDA Agents, Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K052714 is the FDA 510(k) clearance record for RAVE COMPOSITE BRACKET, a class II device, cleared for FDA Agents on under FDA product code DYW (Bracket, Plastic, Orthodontic). FDA records list one 510(k) clearance for FDA Agents. As of , FDA records show no recalls naming K052714.

Clearance record

Decision date
Received
(27 days to decision)
Product code
DYW Bracket, Plastic, Orthodontic
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
FDA Agents 17401 Commerce Park Blvd., Tampa FL
510(k) summary
Statement
Third party review
No

Clearances, product code DYW

Trailing 12 months
1 clearance under product code DYW 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 DYW, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260