Cleared Traditional

K991822 - ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH

K991822 is an FDA 510(k) clearance for ALLFIT IMPLANT SYSTEM, manufactured by Dr. Ihde Dental AG Switzerland. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 811-day FDA review.

K991822 · Dr. Ihde Dental AG Switzerland · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
811d
Days
Class 2
Risk

K991822 is an FDA 510(k) clearance for the ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM.... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dr. Ihde Dental AG Switzerland (New York, US). The FDA issued a Cleared decision on August 15, 2001 after a review of 811 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 Dr. Ihde Dental AG Switzerland devices

FDA 510(k) Submission Details - K991822

510(k) Number K991822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1999
Decision Date August 15, 2001
Days to Decision 811 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
684d slower than avg
Panel avg: 127d · This submission: 811d
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 1031
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K991822.
3I LOCATER ABUTMENT SYSTEM
K012911 · Implant Innovations, Inc. · Sep 2001
QUANTUM VERSATILITY IMPLANT SYSTEM
K991250 · Quantum Bioengineering, Ltd. · Sep 2001
ITI DENTAL IMPLANT SYSTEM
K012757 · Straumann USA · Aug 2001
LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS
K002037 · Lifecore Biomedical, Inc. · May 2001
ITI DENTAL IMPLANT SYSTEM
K010291 · Straumann USA · May 2001
THE MAESTRO SYSTEM
K010458 · BioHorizons Implant Systems, Inc. · May 2001