Cleared Traditional

DENTAL ORAL CARE SYSTEMS & COMPONENTS (K844480) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844480 · Advanced Bio Systems, Inc. · Dental device
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Jun 1985
Decision
212d
Days
Class 2
Risk

K844480 is an FDA 510(k) clearance for the DENTAL ORAL CARE SYSTEMS & COMPONENTS. Classified as Denture Repair Kit (product code EBO), Class II - Special Controls.

Submitted by Advanced Bio Systems, Inc. (Valley Stream, US). The FDA issued a Cleared decision on June 19, 1985 after a review of 212 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3570 - 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 Advanced Bio Systems, Inc. devices

Submission Details

510(k) Number K844480 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 19, 1984
Decision Date June 19, 1985
Days to Decision 212 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 127d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBO Denture Repair Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3570
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.