Cleared Traditional

K981990 - MRS-400, MAXI 400, MRSL-400, MAXI 400L

K981990 is an FDA 510(k) clearance for MRS-400, manufactured by D.B.I. America Corp.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K981990 · D.B.I. America Corp. · Dental device
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Jun 1998
Decision
14d
Days
Class 1
Risk

K981990 is an FDA 510(k) clearance for the MRS-400, MAXI 400, MRSL-400, MAXI 400L. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by D.B.I. America Corp. (Tampa, US). The FDA issued a Cleared decision on June 22, 1998 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all D.B.I. America Corp. devices

FDA 510(k) Submission Details - K981990

510(k) Number K981990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1998
Decision Date June 22, 1998
Days to Decision 14 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 127d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Underwriters Laboratories, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 113
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K981990.
MILLENNIUM
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