Cleared Traditional

K981663 - DIGITAL DOC

K981663 is an FDA 510(k) clearance for DIGITAL DOC, manufactured by Digital Doc, LLC. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K981663 · Digital Doc, LLC · Dental device
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Aug 1998
Decision
91d
Days
Class 1
Risk

K981663 is an FDA 510(k) clearance for the DIGITAL DOC. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Digital Doc, LLC (Los Angeles, US). The FDA issued a Cleared decision on August 10, 1998 after a review of 91 days - within the typical 510(k) review window.

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 Digital Doc, LLC devices

FDA 510(k) Submission Details - K981663

510(k) Number K981663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1998
Decision Date August 10, 1998
Days to Decision 91 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
36d faster than avg
Panel avg: 127d · This submission: 91d
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
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K981663.
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VIPERCAM
K981534 · Integra Medical · Jul 1998
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K982009 · Scitech Solutions, Inc. · Jun 1998