510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K960270Substantially Equivalent

Dentalogic

Protecs Syringes International Corp., Palm Harobor FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960270 is the FDA 510(k) clearance record for DENTALOGIC, a class II device, cleared for Protecs Syringes International Corp. on under FDA product code EJI (Syringe, Cartridge). FDA records list one 510(k) clearance for Protecs Syringes International Corp. As of , FDA records show no recalls naming K960270.

Clearance record

Decision date
Received
(57 days to decision)
Product code
EJI Syringe, Cartridge
Regulation
21 CFR 872.6770
Device class
Class II
Review panel
Dental
Applicant
Protecs Syringes International Corp. 1247 Florida Ave., Palm Harobor FL
510(k) summary
Statement
Third party review
No

Clearances, product code EJI

Trailing 12 months

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

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