510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K981990Substantially Equivalent

Mrs-400, Maxi 400, Mrsl-400, Maxi 400L

D.B.I. America Corp., Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981990 is the FDA 510(k) clearance record for MRS-400, MAXI 400, MRSL-400, MAXI 400L, a class I device, cleared for D.B.I. America Corp. on under FDA product code EFB (Handpiece, Air-Powered, Dental). FDA records list 2 510(k) clearances for D.B.I. America Corp., from to . As of , FDA records show no recalls naming K981990.

Clearance record

Decision date
Received
(14 days to decision)
Product code
EFB Handpiece, Air-Powered, Dental
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
D.B.I. America Corp. 8194 Woodland Center Blvd., Tampa FL
510(k) summary
Statement
Third party review
Yes

Clearances, product code EFB

Trailing 12 months
4 clearances under product code EFB in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EFB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20261