510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133088Substantially Equivalent

Zx-27

M&M Dental Studio, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K133088 is the FDA 510(k) clearance record for ZX-27, a class I device, cleared for M&M Dental Studio, Inc. on under FDA product code EJX (Anchor, Preformed). FDA records list one 510(k) clearance for M&M Dental Studio, Inc. As of , FDA records show no recalls naming K133088.

Clearance record

Decision date
Received
(459 days to decision)
Product code
EJX Anchor, Preformed
Regulation
21 CFR 872.3130
Device class
Class I
Review panel
Dental
Applicant
M&M Dental Studio, Inc. 420 Lexington Ave., New York NY
510(k) summary
Statement
Third party review
No

Clearances, product code EJX

Trailing 12 months

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

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