Cleared Traditional

O-RING PROSTHETIC ATTACHMENT (K001638) - FDA 510(k) Clearance

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

K001638 · Titan Implants · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
643d
Days
Class 2
Risk

K001638 is an FDA 510(k) clearance for the O-RING PROSTHETIC ATTACHMENT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Titan Implants (Flemington, US). The FDA issued a Cleared decision on March 4, 2002 after a review of 643 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 Titan Implants devices

Submission Details

510(k) Number K001638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2000
Decision Date March 04, 2002
Days to Decision 643 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
516d slower than avg
Panel avg: 127d · This submission: 643d
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 303
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K001638.
TREFOIL System
K172352 · Nobel Biocare AB · Oct 2017
TREFOIL System
K170135 · Nobel Biocare AB · May 2017
NobelZygoma 0°
K161598 · Nobel Biocare AB · Mar 2017
DENTSPLY PRECISION TORQUE SYSTEM
K964046 · Dentsply Intl. · Mar 1997
LORENZ SURGICAL THREADED DENTAL IMPLANT
K941619 · Biomet, Inc. · Sep 1994
LORENZ SURGICAL CYLINDER DENTAL IMPLANT
K941620 · Biomet, Inc. · Sep 1994