Cleared Traditional

K980106 - THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES

K980106 is an FDA 510(k) clearance for THE PROMA PERCEPTION, manufactured by Proma, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K980106 · Proma, Inc. · Dental device
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Aug 1998
Decision
203d
Days
Class 1
Risk

K980106 is an FDA 510(k) clearance for the THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Proma, Inc. (Carson, US). The FDA issued a Cleared decision on August 3, 1998 after a review of 203 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Proma, Inc. devices

FDA 510(k) Submission Details - K980106

510(k) Number K980106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1998
Decision Date August 03, 1998
Days to Decision 203 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
76d slower than avg
Panel avg: 127d · This submission: 203d
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 123
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