510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112508Substantially Equivalent

I-Root 100

S-Denti Co., Ltd., Tae Kye Nam, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112508 is the FDA 510(k) clearance record for I-ROOT 100, cleared for S-Denti Co., Ltd. on under FDA product code LQY (Locator, Root Apex). FDA records list 4 510(k) clearances for S-Denti Co., Ltd., from to . As of , FDA records show no recalls naming K112508.

Clearance record

Decision date
Received
(294 days to decision)
Product code
LQY Locator, Root Apex
Device class
Unclassified
Review panel
Unknown
Applicant
S-Denti Co., Ltd. Valley 6,481-4, Tae Kye Nam, KR
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