Cleared Traditional

K941554 - SUSTAIN HEX HA-COATED CYLINDER ENDOSSEO...

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

K941554 · Lifecore Biomedical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 611
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K941554.
BRANEMARK-HEALING CAPS, DCC045, DCC046, DCC104
K934826 · Nobelpharma USA, Inc. · Aug 1994
BRANEMARK SYSTEM ESTHETICONE NON-ROTATIONAL SYSTEM
K934827 · Nobelpharma USA, Inc. · Aug 1994
BRANEMARK SYSTEM TEMPORARY SOLUTIONS
K925766 · Nobelpharma USA, Inc. · Aug 1994
RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM
K931468 · Lifecore Biomedical, Inc. · Jul 1994
BRANEMARK SYST. HAND INST. DIA 297 & SDIA 276
K925483 · Nobelpharma USA, Inc. · May 1994
TAPERED ABUTMENT AND RELATED COMPONENTS
K933969 · Implant Innovations, Inc. · Apr 1994