Cleared Traditional

K924155 - SURA SNAP

K924155 is the FDA 510(k) clearance for SURA SNAP by Metalor Dental USA Corp.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K924155 · Metalor Dental USA Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
267d
Days
Class 2
Risk

K924155 is an FDA 510(k) clearance for the SURA SNAP. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Metalor Dental USA Corp. (Rockville Centre, US). The FDA issued a Cleared decision on May 12, 1993 after a review of 267 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 Metalor Dental USA Corp. devices

Submission Details

510(k) Number K924155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1992
Decision Date May 12, 1993
Days to Decision 267 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 127d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 672
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K924155.
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