510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982537Substantially Equivalent

Tokuyama Sofreliner

Tokuyama America Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982537 is the FDA 510(k) clearance record for TOKUYAMA SOFRELINER, a class II device, cleared for Tokuyama America, Inc. on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list 22 510(k) clearances for Tokuyama America, Inc., from to . As of , FDA records show no recalls naming K982537.

Clearance record

Decision date
Received
(34 days to decision)
Product code
EBI Resin, Denture, Relining, Repairing, Rebasing
Regulation
21 CFR 872.3760
Device class
Class II
Review panel
Dental
Applicant
Tokuyama America, Inc. 2000 M St. NW Suite 700, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code EBI

Trailing 12 months
10 clearances under product code EBI in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EBI, trailing twelve months
MonthClearances
November 20253
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20263
August 20262
September 20260
October 20260