Cleared Traditional

K935544 - 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION

K935544 is an FDA 510(k) clearance for 3I STANDARD THREADED/SELF-TAPPING THREA..., manufactured by Implant Innovations International, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 486-day FDA review.

K935544 · Implant Innovations International, Inc. · Dental device
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Mar 1995
Decision
486d
Days
Class 2
Risk

K935544 is an FDA 510(k) clearance for the 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Implant Innovations International, Inc. (West Palm Baeach, US). The FDA issued a Cleared decision on March 13, 1995 after a review of 486 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 Implant Innovations International, Inc. devices

FDA 510(k) Submission Details - K935544

510(k) Number K935544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1993
Decision Date March 13, 1995
Days to Decision 486 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
359d slower than avg
Panel avg: 127d · This submission: 486d
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 868
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K935544.
BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE
K945398 · Nobelpharma USA, Inc. · Apr 1995
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K951111 · Lifecore Biomedical, Inc. · Mar 1995
STERI-OSS TITANIUM ALLOY SCREW SERIES IMPLANT FOR SINGLE STAGE SURGICAL PLACEMENT
K944158 · Steri-Oss, Inc. · Mar 1995
BRANEMARK SYSTEM 3.3MM FIXTURE
K944683 · Nobelpharma USA, Inc. · Mar 1995
KIS-II IMPLANT FIXTURES
K943971 · Implant Center of the Palm Beaches · Mar 1995
KIS-II NON-ANGULATED ABUTMENTS
K943984 · Implant Center of the Palm Beaches · Mar 1995