510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911118Substantially Equivalent

Dtf-1000Ll,dtf-1000

Cp Medical, Huntington Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911118 is the FDA 510(k) clearance record for DTF-1000LL,DTF-1000, a class I device, cleared for Cp Medical on under FDA product code EIB (Syringe, Irrigating (Dental)). FDA records list 32 510(k) clearances for Cp Medical, from to . As of , FDA records show no recalls naming K911118.

Clearance record

Decision date
Received
(253 days to decision)
Product code
EIB Syringe, Irrigating (Dental)
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Cp Medical P.O. Box 5668, Huntington Beach CA
Third party review
No

Clearances, product code EIB

Trailing 12 months

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

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