Cleared Special

K072768 - RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS

K072768 is an FDA 510(k) clearance for RESTORE, manufactured by Lifecore Biomedical, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 25-day FDA review.

K072768 · Lifecore Biomedical, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
25d
Days
Class 2
Risk

K072768 is an FDA 510(k) clearance for the RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS. 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 October 23, 2007 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K072768

510(k) Number K072768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2007
Decision Date October 23, 2007
Days to Decision 25 days
Submission Type Special
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
103d faster than avg
Panel avg: 128d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 1547
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K072768.
GS FIXTURE SYSTEM
K072896 · Osstem Implant Co., Ltd. · Nov 2007
Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX
K062542 · Z-Systems AG · Oct 2007
OLYMPUS DENTAL IMPLANT SYSTEM
K071070 · Keystone Dental, Inc. · Oct 2007
HDC STERILE SPIDER SCREW
K071851 · Hdc S.R.L. · Oct 2007
MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM
K070601 · Intra-Lock International · Oct 2007
BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM
K071638 · BioHorizons Implant Systems, Inc. · Oct 2007
K072768 · RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS
Download PDF FDA Summary Lifecore Biomedical, …