510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020157Substantially Equivalent

Temporary Crown and Bridge Material

J. Morita USA, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K020157 is the FDA 510(k) clearance record for TEMPORARY CROWN AND BRIDGE MATERIAL, a class II device, cleared for J. Morita USA, Inc. on under FDA product code EBG (Crown And Bridge, Temporary, Resin). FDA records list 52 510(k) clearances for J. Morita USA, Inc., from to . As of , FDA records show no recalls naming K020157.

Clearance record

Decision date
Received
(46 days to decision)
Product code
EBG Crown And Bridge, Temporary, Resin
Regulation
21 CFR 872.3770
Device class
Class II
Review panel
Dental
Applicant
J. Morita USA, Inc. 601 13th St. NW, Washington DC
510(k) summary
Statement
Third party review
No

Clearances, product code EBG

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