Cleared Traditional

K963521 - IMZ TWIN PLUS - CYLINDER

K963521 is an FDA 510(k) clearance for IMZ TWIN PLUS - CYLINDER, manufactured by Imz, GmbH. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 337-day FDA review.

K963521 · Imz, GmbH · Dental device
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Aug 1997
Decision
337d
Days
Class 2
Risk

K963521 is an FDA 510(k) clearance for the IMZ TWIN PLUS - CYLINDER. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Imz, GmbH (Potomac, US). The FDA issued a Cleared decision on August 6, 1997 after a review of 337 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Imz, GmbH devices

FDA 510(k) Submission Details - K963521

510(k) Number K963521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date August 06, 1997
Days to Decision 337 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 127d · This submission: 337d
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 K963521.
ROOTFORM DENTAL IMPLANT SYSTEM
K954758 · Swiss Dental Center · Aug 1997
BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEM
K972029 · Bicon, Inc. · Aug 1997
IMZ TWIN PLUS SCREW
K963520 · Imz, GmbH · Aug 1997
ENDOSSEOUS DENTAL IMPLANT
K971578 · Straumann USA · Jun 1997
EDOSSEOUS DENTAL IMPLANT
K970127 · Sulzer Calcitek, Inc. · Jun 1997
SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM
K970752 · Sulzer Calcitek, Inc. · Jun 1997