510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864053Substantially Equivalent

Tubulitec Liner

Dental Dimensions Supply Co., Wantagh NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864053 is the FDA 510(k) clearance record for TUBULITEC LINER, a class II device, cleared for Dental Dimensions Supply Co. on under FDA product code EJK (Liner, Cavity, Calcium Hydroxide). FDA records list 4 510(k) clearances for Dental Dimensions Supply Co., from to . As of , FDA records show no recalls naming K864053.

Clearance record

Decision date
Received
(50 days to decision)
Product code
EJK Liner, Cavity, Calcium Hydroxide
Regulation
21 CFR 872.3250
Device class
Class II
Review panel
Dental
Applicant
Dental Dimensions Supply Co. 1028 Mclean Ave., Wantagh NY
Third party review
No

Clearances, product code EJK

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