Cleared Traditional

K895283 - PROSTHETIC RESTORATION DEVICE

K895283 is an FDA 510(k) clearance for PROSTHETIC RESTORATION DEVICE, manufactured by Swiss Precision Mfg. Corp.. The device is a Class 1 Dental device with product code EBL cleared through the Traditional 510(k) pathway after a 174-day FDA review.

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

FDA 510(k) Submission Details - K895283

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.

EBL Device Classification - Class 1, General Controls

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.