510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K131907Substantially Equivalent

Raypex 6

Dentsply International, Inc., York PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131907 is the FDA 510(k) clearance record for RAYPEX 6, cleared for Dentsply International, Inc. on under FDA product code LQY (Locator, Root Apex). FDA records list 59 510(k) clearances for Dentsply International, Inc., from to . As of , FDA records show no recalls naming K131907.

Clearance record

Decision date
Received
(219 days to decision)
Product code
LQY Locator, Root Apex
Device class
Unclassified
Review panel
Unknown
Applicant
Dentsply International, Inc. 221 W. Philadelphia St., Suite 60, York PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LQY

Trailing 12 months
1 clearance under product code LQY in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LQY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260