Cleared Traditional

K941554 - SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM

K941554 is an FDA 510(k) clearance for SUSTAIN HEX HA-COATED CYLINDER ENDOSSEO..., manufactured by Lifecore Biomedical, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K941554 · Lifecore Biomedical, Inc. · Dental device
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Jul 1994
Decision
114d
Days
Class 2
Risk

K941554 is an FDA 510(k) clearance for the SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Lifecore Biomedical, Inc. (Chaska, US). The FDA issued a Cleared decision on July 22, 1994 after a review of 114 days - within the typical 510(k) review window.

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 Lifecore Biomedical, Inc. devices

FDA 510(k) Submission Details - K941554

510(k) Number K941554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1994
Decision Date July 22, 1994
Days to Decision 114 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
13d faster than avg
Panel avg: 127d · This submission: 114d
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 1207
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K941554.
BRANEMARK SYSTEM TEMPORARY SOLUTIONS
K925766 · Nobelpharma USA, Inc. · Aug 1994
INTEGRAL III BIOINTEGRATED DENTAL IMPLANT SYSTEM
K925490 · Calcitek, Inc. · Aug 1994
INTERPORE CYLINDRICAL HEX HYDROXYAPATITE COATED IMPLANT, 3.3 MM DIAM.
K922872 · Interpore Intl. · Jul 1994
RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM
K931468 · Lifecore Biomedical, Inc. · Jul 1994
IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM
K932123 · Implant Innovations International, Inc. · May 1994
BRANEMARK SYST. HAND INST. DIA 297 & SDIA 276
K925483 · Nobelpharma USA, Inc. · May 1994