Cleared Special

K023631 - ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS

K023631 is an FDA 510(k) clearance for ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUT..., manufactured by Astra Tech, Inc.. The device is a Class 2 Dental device with product code NHA cleared through the Special 510(k) pathway after a 9-day FDA review.

K023631 · Astra Tech, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
9d
Days
Class 2
Risk

K023631 is an FDA 510(k) clearance for the ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS. 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 Astra Tech, Inc. (Northborough, US). The FDA issued a Cleared decision on November 7, 2002 after a review of 9 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.

FDA 510(k) Submission Details - K023631

510(k) Number K023631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2002
Decision Date November 07, 2002
Days to Decision 9 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
119d faster than avg
Panel avg: 128d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

NHA Device Classification - Class 2, Special Controls

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 715
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K023631.
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K022795 · BioHorizons Implant Systems, Inc. · Aug 2002
OCO DENTAL IMPLANT
K021460 · "O" Co., Inc. · May 2002
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K014175 · Sulzer Dental, Inc. · Mar 2002
K023631 · ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS
Download PDF FDA Summary Astra Tech, Inc.