Cleared Special

K053643 - STAGE- 1 TEMPORARY/HEALING CAP

K053643 is the FDA 510(k) clearance for STAGE- 1 TEMPORARY/HEALING CAP by Lifecore Biomedical, Inc.. It is a Class 2 Dental device (product code NHA) cleared through the Special 510(k) pathway after a 24-day FDA review.

K053643 · Lifecore Biomedical, Inc. · Dental device
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Jan 2006
Decision
24d
Days
Class 2
Risk

K053643 is an FDA 510(k) clearance for the STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Lifecore Biomedical, Inc. (Chaska, US). The FDA issued a Cleared decision on January 23, 2006 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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.

View all Lifecore Biomedical, Inc. devices

Submission Details

510(k) Number K053643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2005
Decision Date January 23, 2006
Days to Decision 24 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: 127d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 468
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K053643.
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PREFORMANCE POSTS
K053170 · Implant Innovations, Inc. · Feb 2006
PROCERA IMPLANT BRIDGE ZIRCONIA
K053091 · Nobel Biocare AB · Jan 2006
STRAUMANN COMPUTER AIDED RESTORATION SERVICE
K052272 · Straumann USA · Jan 2006
MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS
K052648 · Implant Innovations, Inc. · Oct 2005
ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED)
K052600 · Zimmer Dental, Inc. · Oct 2005