Cleared Special

K022038 - SPI ONETIME DENTAL IMPLANT

K022038 is an FDA 510(k) clearance for SPI ONETIME DENTAL IMPLANT, manufactured by Paxmed International. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 21-day FDA review.

K022038 · Paxmed International · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
21d
Days
Class 2
Risk

K022038 is an FDA 510(k) clearance for the SPI ONETIME DENTAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Paxmed International (San Diego, US). The FDA issued a Cleared decision on July 15, 2002 after a review of 21 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 - K022038

510(k) Number K022038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2002
Decision Date July 15, 2002
Days to Decision 21 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
107d faster than avg
Panel avg: 128d · This submission: 21d
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 1482
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K022038.
3A DENTAL IMPLANT SYSTEM
K011879 · Osseco Biosource, Ltd. · Aug 2002
SCREWLINE
K022425 · Altatec Biotechnologies N.A., Inc. · Aug 2002
ENDOSSOUS IMPLANTS
K021322 · Intra-Lock International · Jul 2002
XIVE DENTAL IMPLANT SYSTEM
K021318 · Friadent GmbH · Jul 2002
ERA IMPLANT
K021045 · Sterngold · Jun 2002
MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM
K021833 · Blue Sky Bio · Jun 2002
K022038 · SPI ONETIME DENTAL IMPLANT
Download PDF FDA Summary Paxmed International