Cleared Traditional

PROSTHETIC RESTORATION DEVICE (K895283) - FDA 510(k) Clearance

Class I Dental device.

K895283 · Swiss Precision Mfg. Corp. · Dental device
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Feb 1990
Decision
174d
Days
Class 1
Risk

K895283 is an FDA 510(k) clearance for the PROSTHETIC RESTORATION DEVICE. Classified as Pin, Retentive And Splinting, And Accessory Instruments (product code EBL), Class I - General Controls.

Submitted by Swiss Precision Mfg. Corp. (Bayshore, US). The FDA issued a Cleared decision on February 14, 1990 after a review of 174 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3740 - 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 Swiss Precision Mfg. Corp. devices

Submission Details

510(k) Number K895283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1989
Decision Date February 14, 1990
Days to Decision 174 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 127d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EBL Pin, Retentive And Splinting, And Accessory Instruments
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3740
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.