510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K151540Substantially Equivalent

MC BIO Supertack Tack 3mm, 4mm and 5mm

Eli-KA Technologies LLC, Monrovia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151540 is the FDA 510(k) clearance record for MC BIO Supertack Tack 3mm, 4mm and 5mm, a class II device, cleared for Eli-Ka Technologies on under FDA product code DZL (Screw, Fixation, Intraosseous). FDA records list one 510(k) clearance for Eli-Ka Technologies. As of , FDA records show no recalls naming K151540.

Clearance record

Decision date
Received
(353 days to decision)
Product code
DZL Screw, Fixation, Intraosseous
Regulation
21 CFR 872.4880
Device class
Class II
Review panel
Dental
Applicant
Eli-Ka Technologies 209 Madison Ave. Suite-D, Monrovia CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DZL

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