Cleared Traditional

K943971 - KIS-II IMPLANT FIXTURES

K943971 is an FDA 510(k) clearance for KIS-II IMPLANT FIXTURES, manufactured by Implant Center of the Palm Beaches. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K943971 · Implant Center of the Palm Beaches · Dental device
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Mar 1995
Decision
198d
Days
Class 2
Risk

K943971 is an FDA 510(k) clearance for the KIS-II IMPLANT FIXTURES. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Implant Center of the Palm Beaches (N. Palm Beach, US). The FDA issued a Cleared decision on March 1, 1995 after a review of 198 days - an extended review cycle.

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. Standard predicate reliance. 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 Implant Center of the Palm Beaches devices

FDA 510(k) Submission Details - K943971

510(k) Number K943971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1994
Decision Date March 01, 1995
Days to Decision 198 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
71d slower than avg
Panel avg: 127d · This submission: 198d
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 867
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K943971.
STERI-OSS TITANIUM ALLOY SCREW SERIES IMPLANT FOR SINGLE STAGE SURGICAL PLACEMENT
K944158 · Steri-Oss, Inc. · Mar 1995
3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION
K935544 · Implant Innovations International, Inc. · Mar 1995
BRANEMARK SYSTEM 3.3MM FIXTURE
K944683 · Nobelpharma USA, Inc. · Mar 1995
KIS-II NON-ANGULATED ABUTMENTS
K943984 · Implant Center of the Palm Beaches · Mar 1995
RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEM
K944069 · Lifecore Biomedical, Inc. · Feb 1995
BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEM
K944964 · Nobelpharma USA, Inc. · Feb 1995