510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K983547Substantially Equivalent

Protech Plus

Protech, Inc., Boca Raton FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983547 is the FDA 510(k) clearance record for PROTECH PLUS, a class II device, cleared for Protech, Inc. on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list one 510(k) clearance for Protech, Inc. As of , FDA records show no recalls naming K983547.

Clearance record

Decision date
Received
(90 days to decision)
Product code
EBI Resin, Denture, Relining, Repairing, Rebasing
Regulation
21 CFR 872.3760
Device class
Class II
Review panel
Dental
Applicant
Protech, Inc. 6421 Congress Ave., #102, Boca Raton FL
510(k) summary
Statement
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