Cleared Traditional

K954758 - ROOTFORM DENTAL IMPLANT SYSTEM

K954758 is an FDA 510(k) clearance for ROOTFORM DENTAL IMPLANT SYSTEM, manufactured by Swiss Dental Center. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 672-day FDA review.

K954758 · Swiss Dental Center · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
672d
Days
Class 2
Risk

K954758 is an FDA 510(k) clearance for the ROOTFORM DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Swiss Dental Center (San Luis Obispo, US). The FDA issued a Cleared decision on August 18, 1997 after a review of 672 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Swiss Dental Center devices

FDA 510(k) Submission Details - K954758

510(k) Number K954758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1995
Decision Date August 18, 1997
Days to Decision 672 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
545d slower than avg
Panel avg: 127d · This submission: 672d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

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 1046
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K954758.
KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS
K961381 · The Emerging Technologies Group · Sep 1997
3I INNOVATIVE IMPLANTS AND COVER SCREWS
K972444 · Implant Innovations, Inc. · Aug 1997
THE PERIOSEAL DENTAL IMPLANT
K965032 · Perioseal · Aug 1997
BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEM
K972029 · Bicon, Inc. · Aug 1997
IMZ TWIN PLUS SCREW
K963520 · Imz, GmbH · Aug 1997
IMZ TWIN PLUS - CYLINDER
K963521 · Imz, GmbH · Aug 1997