510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915243Substantially Equivalent

Touch 'N Heat Model 5002, Modification

Analytic Technology, Redmond WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915243 is the FDA 510(k) clearance record for TOUCH 'N HEAT MODEL 5002, MODIFICATION, a class I device, cleared for Analytic Technology on under FDA product code EKM (Gutta-Percha). FDA records list 9 510(k) clearances for Analytic Technology, from to . As of , FDA records show no recalls naming K915243.

Clearance record

Decision date
Received
(82 days to decision)
Product code
EKM Gutta-Percha
Regulation
21 CFR 872.3850
Device class
Class I
Review panel
Dental
Applicant
Analytic Technology 15233 Northeast 90th St., Redmond WA
510(k) summary
Statement
Third party review
No

Clearances, product code EKM

Trailing 12 months

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

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