Cleared Traditional

K000799 - BELMONT UNIT, MODEL 2000 SERIES

K000799 is an FDA 510(k) clearance for BELMONT UNIT, manufactured by Belmont Equipment Corp.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K000799 · Belmont Equipment Corp. · Dental device
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May 2000
Decision
65d
Days
Class 1
Risk

K000799 is an FDA 510(k) clearance for the BELMONT UNIT, MODEL 2000 SERIES. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Belmont Equipment Corp. (Somerset, US). The FDA issued a Cleared decision on May 17, 2000 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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.

FDA 510(k) Submission Details - K000799

510(k) Number K000799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2000
Decision Date May 17, 2000
Days to Decision 65 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 128d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 Peers - EIA Unit, Operative Dental

All 268
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K000799.
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K000967 · A-Dec, Inc. · May 2000
K000799 · BELMONT UNIT, MODEL 2000 SERIES
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