510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992854Substantially Equivalent

Artificial Teeth (Acrylic Teeth)

Masterdent, Ltda, Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992854 is the FDA 510(k) clearance record for ARTIFICIAL TEETH (ACRYLIC TEETH), a class II device, cleared for Masterdent Ltda. on under FDA product code ELM (Denture, Plastic, Teeth). FDA records list one 510(k) clearance for Masterdent Ltda. As of , FDA records show no recalls naming K992854.

Clearance record

Decision date
Received
(167 days to decision)
Product code
ELM Denture, Plastic, Teeth
Regulation
21 CFR 872.3590
Device class
Class II
Review panel
Dental
Applicant
Masterdent Ltda. 7150 NW 72 Ave., Miami FL
510(k) summary
Statement
Third party review
No

Clearances, product code ELM

Trailing 12 months

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

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